DETAILED ACTION
Final Rejection
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of Group I, claims 1-7,9-11 and 14-17 in the reply filed on 11/19/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of Group I claims 1-7,9-11 and 14-17 has been treated as an election without traverse (MPEP § 818.01(a)).
3. Applicant's election with traverse of species in the reply filed on 11/19/2025 is acknowledged. The traversal is on the ground(s) that “a chemical compound that mimics a cell receptor for the analyte protein” is not a species of receptor”. Rather, the chemical compound “mimics a feature of a cell receptor for the protein’. Nonetheless, responsive to the requirement to elect a Receptor Species from the options presented, Applicant hereby elects (11) ACE2 as the Receptor Species, which reads on claims 1-7, 9-11, and 14-17.
This is found persuasive and the election of species of a receptor is withdrawn. Applicant has amended the claims to comprise both chemical compounds: 1-pyrenebutyric acid N- hydroxysuccinimide ester (PBSE) and cysteamine. The receptor ACE-2 and both the chemical compounds: 1-pyrenebutyric acid N- hydroxysuccinimide ester (PBSE) and cysteamine will be examined in view of the amendment to the independent claim 1.
The requirement for restriction/election as above is made FINAL.
Status of Claims
4. Claims 1-7,9-11 and 14-26 as amended and filed on 11/19/2025 are Pending
5. Claims 18-26 are cancelled by the applicant on 03/19/2026.
6. Claims 1-7, 9-11 and 14-17 are under examination in this office action.
Priority
7. This application claims the benefit of U.S. Provisional Application No. 63/065,462, filed on August 13, 2020.
Information Disclosure Statement
8. The information disclosure statements (IDSs) submitted on 02/07/2023, 10/25/2023, 05/06/2024, 01/07/2025 and 03/19/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
9. 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.
Claim 10: The instant claim 10, for the examination purpose, is interpreted as directed to the sensor of claim 1 for detection of an analyte a protein which is interpreted as Spike (S) protein of a SARS-CoV-2 or SARS-CoV virus. The limitation at least one chemical compound (1-pyrenebutyric acid N- hydroxysuccinimide ester (PBSE), and cysteamine) mimics a feature of a cell receptor for the protein (ACE-2 cell entry receptor of SARS-CoV-2 or SARS-CoV virus). The specification para [0010], [0031], [0034], [0047], [0079]) has support for “a protein” and the claimed chemical compounds (1-pyrenebutyric acid N- hydroxysuccinimide ester (PBSE), and cysteamine) that mimic ACE-2 cell entry receptor of SARS-CoV-2 or SARS-CoV virus (See, para [0010], [0038], [0040], and elsewhere in the specification.
Claim 6: In claim 6, SARS1 is interpreted as SARS-CoV (See, specification para [0041], and elsewhere in the specification. Applicant may amend “SARS1” to SARS-CoV in light of the standard nomenclature for the virus known and practiced in the art.
Withdrawn Claim Rejections - 35 USC § 112
10. Withdrawn rejection of claim 10 under 35 U.S.C. 112(b) in view of applicant’s amendment to the claim 10.
Claim Rejections - 35 USC § 103 (Modified)
11. 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 (i.e., changing from AIA to pre-AIA ) 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.
12. Claims 1, 9, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al 2019 (US20190313944A1 published 10/17/2019, earlier priority date of 04/12/2019 to the application US 16/383,220), and further in view of Seo et al 2020 (ACS Nano 2020, 14, 5135−5142) and Layqah et al 2019 (Microchimica Acta (2019) 186: 224).
Claim 1, 9, and 14-17: Sun et al 2019 (US20190313944A1) is in the art and teaches molecularly imprinted (MIP) electrochemical sensors comprising one or more layers of graphene between the one or more layers of metal and the layer of molecularly imprinted polymer, the one or more layers of graphene being in electrical communication with the one or more layers of metal and the layer of molecularly imprinted polymer.to detect one or more analytes in a sample, to detect and/or diagnose a disease or condition in a subject (See, abstract, claims 1, 14-15). Besides the size, shape, and orientation of functional monomers, the selectivity of MIP to the target molecule is performed by the covalent or non-covalent bonding that happens between the template molecule and the polymer matrix that enables the creation of stable and selective “artificial receptors.” It utilizes associative self-assembly between target analytes and material precursors to create a molecular “lock and key” architecture within an electrochemical sensor for ultrasensitive and selective detection (See, para [0141]).Sun et al 2019 teaches following limitations of the instant claim 1: A sensor, comprising: a polymer layer molecularly imprinted for an analyte; a metal layer; an electrocatalytic layer disposed between the polymer layer and the metal layer, wherein the electrocatalytic layer comprises graphene, and electrodes in operative arrangement with the polymer layer and configured to provide a signal indicative of a resistance. The sensor is functionalized with oxygen-containing functional groups such as epoxides, carbonyls, carboxyls and alcohols resulting in “Graphene oxide” (see, para [0073]). Typically, the carbon to oxygen ratio of graphene oxide is about three to about one. In some aspect, graphene is graphene oxide. The disease is Alzheimer's disease, and/or the one or more analytes are e.g. styrene; 2,3,6,7-tetramethyl-octane for which the MIP is developed / printed (see, para [0095]). (See, abstract, claims 1, 14-14, 31, para [0007], [0016], [0011], claims 35, 38-39, claim 32-33, para [0008], [0141], [0073], [0095]).
Sun et al 2019 (US20190313944A1) does not teach functionalization of the claimed sensor with 1-pyrenebutyric acid N- hydroxysuccinimide ester (PBSE) and cysteamine.
Seo et al 2020 is in the art and teaches rapid detection of COVID-19 causative virus (SARS-CoV-2) in human nasopharyngeal swab specimens using field-effect transistor-based biosensor. The sensor was produced by coating graphene sheets of the FET with a specific antibody against SARS-CoV-2 spike protein by using graphene as a sensing material, and SARS-CoV-2 spike antibody is conjugated onto the graphene sheet via 1-pyrenebutyric acid N-hydroxysuccinimide ester (PBSE), which is an interfacing molecule as a probe linker. Thus, the PBSE functionalizes the biosensor and is functionally equivalent to Seo et al 2020 functionalization with oxygen-containing functional groups such as epoxides, carbonyls, carboxyls and alcohols resulting in “Graphene oxide”.
The performance of the sensor was determined using antigen protein, cultured virus, and nasopharyngeal swab specimens from COVID-19 patients to detect the SARS-CoV-2 spike protein at concentrations of 1 fg/mL in phosphate-buffered saline and 100 fg/mL clinical transport medium (See, abstract). The FET sensor successfully detected SARS-CoV-2 in culture medium (limit of detection [LOD]: 1.6 × 101 pfu/mL) and clinical samples (LOD: 2.42 × 102 copies/mL), the biosensor device is a highly sensitive immunological diagnostic method for COVID-19 (SARS-CoV-2 virus) that requires no sample pretreatment or labeling (See, abstract, Figures 1-2).
Thus, the combined prior art teachings of Sun et al 2020 and Seo et al 2020 as recited supra teaches a molecularly imprinted (MIP) electrochemical sensors as claimed instant claim 1 except functionalization with cysteamine.
Layqah et al 2019 is in the art and teaches cysteamine and immobilization of HCoV antigen on the electrode in a biosensor design for an electrochemical immunosensor for the human coronavirus (HCoV) using an array of gold nanoparticle-modified carbon electrodes (See, page 3, col 1 last para; page 4 Scheme 1).
Sun et al 2019 (US20190313944A1) teaches added limitations of instant claims 9 and 14-17 (dependent on claim 1) as recited below:
Claim 9 added limitation, wherein the electrocatalytic layer further comprises potassium ferrocyanide (reads on doping by disclosing wherein the one more layers of graphene comprise potassium ferrocyanide) (See, abstract, para [0007], [0075], [0117], [0135]- [0136] and [0142], claim 15).
Claim 14 added limitation, wherein the metal layer comprises chromium (See, abstract, para [0006], claims 1, 4).
Claim 15 added limitation, further comprising a silicon substrate (See, abstract, claim 1).
Claim 16: A detector comprising: the sensor of claim 1; and a voltage source configured to apply a voltage to the polymer layer (See, para [078], [0153]).
Claim 17: The detector of claim 16, further comprising an ohmmeter in operative arrangement with the electrodes and configured to output a measurement of the resistance (See, para [0008], [0011], [0118], claims 32-33, 35, 38-39).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art teachings of Sun et al 2019 on the molecularly imprinted (MIP) biosensor with additional teachings of Seo et al 2020 on 1-pyrenebutyric acid N-hydroxysuccinimide ester and Layqah et al 2019 on cysteamine and incoroportae those to functionalize the sensor in place of functionally equivalent epoxides, carbonyls and MIP the sensor for specific analyte and for detection of a specific analyte and to arrive at the invention of claims 1, 9, and 14-17. One of ordinary skills in the art would have been motivated to modify the molecularly imprinted (MIP) biosensor of Sun et al 2019 by combining the applied additional prior art teachings of Seo et al and Layqah et al 2019 to develop the sensor of instant claim 1 that comprise one or both PBSE and cysteamine for rapid and sensitive biochemical sensor-based diagnostic for the point-of-care use and for a commercial advantage and success. Cysteamine is often chosen over epoxides for this purpose because of its chemical versatility, reactivity, and compatibility with the polymerization environment and PBSE for its thermoelectric performance. One of the ordinary skills would have been apprised of a reasonable expectation of success to arrive at the invention of claims 1, 9, and 14-17 given the combined prior art teachings as applied and as recited supra. This is analogous to some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention of instant claims 1, 9, and 14-17. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
13. Claims 2-6, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Sun et al 2019 (US20190313944A1 published 10/17/2019, earlier priority date of 04/12/2019 to the application US 16/383,220), Seo et al 2020 (ACS Nano 2020, 14, 5135−5142) and Layqah et al 2019 (Microchimica Acta (2019) 186: 224) as applied to claim 1 above and further in view of Huang et al 2020 (Acta Pharmacologica Sinica (2020) 41:1141–1149) and Zhou et al 2020 (Nature, 579, 12 March 2020, pages 270-289).
Claims 2-6, and 10-11: The combined teachings of Sun et al 2019, Seo et al 2020 and Layqah et al 2019 renders obvious the instant claim 1 as recited supra and teachings are incorporated here in entirety. However, the prior arts applied to claim 1 does not teach added limitations of instant claims 2-7, and 10-11.
Huang et al 2020 (See, entire article) teaches added limitations of instant claims 2-7, and 10-11 as follow:
Claim 2-6 and 10-11: Huang et al 2020 is in the art and is directed to structural and functional properties of SARS-CoV-2 spike protein. Huang et al 2020 teaches the analyte is a receptor-binding domain of a virus. The spike (S) protein of SARS-CoV-2, which plays a key role in the receptor recognition and cell membrane fusion process, is composed of two subunits, S1 and S2. The S1 subunit contains a receptor-binding domain that recognizes and binds to the host receptor, ACE-2, an angiotensin-converting enzyme 2 (See, abstract). The S protein on the surface of the virus is a key factor involved in infection. It is a trimeric class I TM glycoprotein responsible for viral entry, the S protein of SARS-CoV-2 mediates receptor recognition, cell attachment, and fusion during viral infection (See, page 1144, col 1, section on Functions of the S protein). A large number of glycosylated S (spike) proteins cover the surface of SARS-CoV-2 and bind to the host cell receptor angiotensin-converting enzyme 2 (ACE2), mediating viral cell entry (See, page 1141, col 1 Introduction, last para).
Zhou et al 2020 teaches that 2019-nCoV (SARS-CoV-2 virus) uses the same cell entry receptor-angiotensin converting enzyme II (ACE-2)-as SARS-CoV (SARS1) (See, abstract last line, entire article).
Seo et al 2020 is in the art and teaches the analyte, SARS-CoV-2 spike protein by disclosing a rapid detection SARS-CoV-2 in human nasopharyngeal swab specimens using field-effect transistor-based biosensor. The sensor was produced by coating graphene sheets of the FET with a specific antibody (the biosensor) that binds to SARS-CoV-2 spike protein (the analyte) by using graphene as a sensing material (See, abstract, Figures 1-2).
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 combined prior art teachings of Sun et al 2019, Seo et al 2020 and Layqah et al 2019 with the additional teachings of Huang et al 2020 and Zhou et al 2020 to develop a MIP sensor for SARS-CoV or SARS-CoV-2 spike protein and RBD (SARS CoV or SARS-CoV-2) spike protein with RBD binds to cellular ACE-2 receptor) arrive at the inventions of claims 2-6 and 11. One of ordinary skills in the art would have been motivated to combine the applied prior art teachings to develop the claimed SARS-COV-2 and SARS-CoV MIP sensor for rapid and sensitive sensor-based diagnostic for detection of the virus infection in the infected or suspected subjects at the point-of-care use and for a commercial advantage and success. One of the ordinary skills would have been apprised of a reasonable expectation of success to arrive at the invention of claims 2-6 and 11 given the combined prior art teachings as applied and as recited supra. This is analogous to some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention of instant claims 2-6 and 10-11. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
14. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Sun et al 2019 (US20190313944A1 published 10/17/2019, earlier priority date of 04/12/2019 to the application US 16/383,220), Seo et al 2020 (ACS Nano 2020, 14, 5135−5142) and Layqah et al 2019 (Microchimica Acta (2019) 186: 224), Huang et al 2020 (Acta Pharmacologica Sinica (2020) 41:1141–1149) and Zhou et al 2020 (Nature, 579, 12 March 2020, pages 270-289) as applied to claim 6 above and further in view of Ogawa et al 2020 (bioRxiv preprint doi: https://doi.org/10.1101/2020.07.21.214932; this version posted July 22, 2020) and Omotuyi et al 2020 (J Comput Chem. 2020;41:2158–2161).
Claim 7: The combined teachings of Sun et al 2019, Seo et al 2020, Layqah et al 2019, Huang et al 2020 and Zhou et al 2020 renders obvious the instant claim 6 as recited supra and teachings are incorporated here in entirety. However, the prior arts applied to claim 6 does not teach added limitations of instant claims 7.
Ogawa et al 2020 teaches a SARS-CoV-2 virus strain with D614G mutation in the SARS-CoV2 Spike protein and the mutation increases infectivity in an ACE2 receptor dependent manner (See, abstract, entire article).
Omotuyi et al 2020 is in the art and teaches atomistic simulation reveals structural mechanisms underlying D614G spike glycoprotein-enhanced fitness in SARS-COV-2. Omotuyi et al 2020 teaches SARS CoV-2 with D614G spike glycoprotein RBD binds to ACE-2 receptor efficiently than the wild type (parent S glycoprotein) virus (See, abstract, entire article).
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 combined prior art teachings of Sun et al 2019, Seo et al 2020, Layqah et al 2019, Huang et al 2020 and Zhou et al 2020 with the additional teachings of Ogawa et al 2020 and Omotuyi et al 2020 on SARS CoV-2 with D614G spike glycoprotein RBD to arrive at the inventions of claim 7 to develop a MIP sensor that would comprise detection of mutant D614G spike glycoprotein. One of the ordinary skills in the art would have been motivated to combine the applied prior art teachings to develop the claimed biosensor of instant claim 7 for rapid and sensitive sensor-based diagnostic for detection of the virus infection in the infected or suspected subjects at the point-of-care use and for a commercial advantage and success. One of the ordinary skills would have been apprised of a reasonable expectation of success to arrive at the invention of claim 7 given the combined prior art teachings as applied and as recited supra. This is analogous to some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention of instant claim 7. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
Double Patenting
15. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 9-11, 14-17,and 18-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-10, 12-15, 17, 20, 22, 27-30, and 41 of copending Application No. 18/260,881 in view of Sun et al 2019 (US20190313944A1 published 10/17/2019, earlier priority date of 04/12/2019 to the application US 16/383,220), Seo et al 2020 (ACS Nano 2020, 14, 5135−5142), Layqah et al 2019 (Microchimica Acta (2019) 186: 224), Huang et al 2020 (Acta Pharmacologica Sinica (2020) 41:1141–1149) and Zhou et al 2020 (Nature, 579, 12 March 2020, pages 270-289).
The combined prior art teachings of Sun et al 2019, Seo et al 2020, Layqah et al 2019, Huang et al 2020 and Zhou et al 2020 as recited supra in the office action are incorporated here in entirety including the applicable obviousness analysis.
Both the instant claims 1-7, 9-11, 14-17, and 18-26 and co-pending claims 1, 3-10, 12-15, 17, 20, 22, 27-30, and 41 are directed to a MIP biosensor that has similar design and components to detect analyte in a sample. The co-pending claims 12-14, 17, 20, 22 are directed to analyte from a virus, SARS-CoV-2 spike (S) glycoprotein similar to the instant claims 2-7, and 10-11.
The comparative analysis of the claims reveals that the co-pending claims 1, 3-10, 12-15, 17, 20, 22, 27-30, and 41 of co-pending Application No. 18/260,881 are variants of instant claims 1-7, 9-11, 14-17, and 18-26 and the co-pending claims are rendered obvious in view of the combined prior art teachings as recited above and incorporated here in entirety for the NSDP rejection.
This is a provisional nonstatutory double patenting rejection.
16. Relevant Prior Arts:
Piletsky et al 2021 (US20210010968A1, published 01/14/2021). Disclosed molecularly imprinted polymer (MIP) electrochemical sensor for detection of an analyte.
Zhao 2010 (Chapter 1 page 1-22, In Biosensor, edited by Pier Andrea Serra, ISBN 978-953-7619-99-2)
Skladal et al 2010 (Chapter 7 page 115-125, In Biosensor, edited by Pier Andrea Serra, ISBN 978-953-7619-99-2).
Fahy et al 2021. WO2021231421A1 (Priority to 63/024,315; date 05/13 2020). Thiol-containing compounds for use in treating coronavirus.
Pohanka et al 2007. Serological Diagnosis of Tularemia in Mice Using the Amperometric Immunosensor. Electroanalysis 19, 2007, No. 24, 2507 – 2512.
Chen et al 2017. Field-Effect Transistor Biosensor for Rapid Detection of Ebola Antigen. Sci Rep 7, 10974 (2017).
Mavrikou et al 2020. Development of a Portable, Ultra-Rapid and Ultra-Sensitive Cell-Based Biosensor for the Direct Detection of the SARS-CoV-2 S1 Spike Protein Antigen. Sensors 2020, 20(11), 3121.
Kirchner et al 2020. Recent developments in carbon-based two-dimensional materials: synthesis and modification aspects for electrochemical sensors. Microchimica Acta (2020) 187: 441.
Tan et al 2020. A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction. Nat Biotechnol. 2020 Sep;38(9):1073-1078. doi: 10.1038/s41587-020-0631-z. Epub 2020 Jul 23. PMID: 32704169.
Response to Arguments
17. Applicant’s arguments with respect to claims 1-7, 9-11 and 14-17 have been considered but are moot because the new ground of rejection does not rely on only the reference applied in the prior rejection of record for teaching or matter specifically challenged in the argument. The office action applied additional teachings of the prior art in view of the amended claims.
Applicant’s Arguments: Applicant has argued against obviousness rejection. Applicant has argued that the primary prior art Sun et al discloses a MIP sensor to detect analyte and fall short of functionalization with PBSE and cysteamine. Applicant argued that although secondary references Seo et al teaches PBSE and Layqah et al teach cysteamine however the references do not teach MIP sensor. Applicant argued that secondary references teach immune sensor using functionalized electrodes.
In Response: Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The office has cited Seo et al for the teachings of limitation PBSE and Layqah et al for the teachings directed to the amended claim limitations directed to cysteamine and not MIP sensor. The primary prior art Sun et al teaches a sensor based on MIP to detect analyte (e.g. Alzheimer's disease and/or the one or more analytes are styrene), see para [0088].
The office action is based on obviousness rejection that involved combination of the prior art teachings as recited supra.
Regarding the “combined” rejection, applicant’s arguments were considered but are not persuasive since the primary reference teaches the sensor components of instant claim for imprinting any antigen/receptor, with the secondary reference suggesting the improved graphene modifications ( PBSE/cysteamine) for sensing viral antigen(s) e.g. spike protein. .
Double-Patenting Rejection
Applicant’s Arguments: Claims 1-7, 9-11, 14-17, and 18-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-10, 12-15, 17, 20, 22, 27- 30, and 41 of copending Application No. 18/260,881 in view of Sun, Seo, Layqah, Huang, and Zhou. Claim 1 of Application No. 18/260,881 recites "a doped silicon layer; a graphene layer on the doped silicon layer; a molecularly imprinted polymer (MIP) layer... on the graphene layer," but does not describe an electrocatalytic layer that "is functionalized with 1-pyrenebutyric acid N-hydroxysuccinimide ester (PBSE) and cysteamine" according to amended claim 1 of the present application. Neither Sun, Seo, Layqah, Huang, Zhou, Ogawa, nor Omotuyi cures the deficiencies of Application No. 18/260,881 for at least the reasons discussed regarding the rejection under 35 U.S.C. § 103. Reconsideration and withdrawal of the double-patenting rejection are respectfully requested.
In Response: The applicant’s arguments regarding nonstatutory double patenting are considered but are not persuasive in view of the obviousness rejection maintained in the office action and the response to applicant’s arguments as recited supra.
Conclusion
17. No claim is allowed.
18. 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).
19. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
Prosecution Insights