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 1-5, 7-12, and 14-21) in the reply filed on 10/31/2025 is acknowledged.
Applicant elected species (ii) Herpes Simplex Virus (HSV).
Group I claims 7-12 reads on elected species HSV and are under examination in this office action.
Group I claims 1-5, and 14-21 are withdrawn from consideration and examination because these claims read on un-elected species SARS-CoV-2 virus.
Group II (unelected group of invention) claims 6, 13, and 22 drawn to a method are withdrawn from consideration and examination.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims (modified)
3. Claims 1-9, 11, and 13-24 as amended on 05/14/2026 are pending.
4. Claims 1-6, and 13-22 are withdrawn from consideration due to restriction/species election.
5. Claims 7-9, 11, and 23-24 as per claim listing amended on 05/14/2026 are under examination.
Priority (modified)
6. This application is the U.S. national stage and is also a continuation- in-part of PCT/US2021/071789, filed October 8, 2021, which claims priority to U.S. Provisional Application No. 63/089,905, filed October 9, 2020, U.S. Provisional Application No. 63/134,690, filed January 7, 2021, and U.S. Provisional Application No. 63/155,963, filed March 3, 2021. The present application also claims priority to U.S. Provisional Application No. 63/489,494, filed March 10, 2023.
The instant pending claims 7-9, and 11 reciting HSV glycoprotein D (gD2) biosensor has subject matter lacking support in CIP PCT/US2021/071789 and the application number 18/296,613 with a filing date of 10/08/2021 and in a provisional application 63/489494 filed on 03/10/2023 with the subject matter indicating incorporated in instant application number 18/296,613.
Therefore, the instant claims 7-9, and 11 has priority date of 10/08/2021.
Information Disclosure Statement
7. Three information disclosure statements (IDSs) submitted on 06/08/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification (modified)
8. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant has listed many references in the specification on pages 76-89. References I listed 49 references (pages 76-80). References II listed 57 references (pages 80-86). Para [00234] listed additional references on pages 86-89.
The applicant has recited additional references (11 pages) by amending specification para [0232]-[0233] on 5/14/2026.
Withdrawn Objection to Specification
9. Withdrawn objection to specification due to applicant’s amendment to the specification that deleted (05/14/2026) embedded hyperlink and/or other form of browser-executable code in para [0232]-[0233].
Claim Rejections - 35 USC § 112 (New Matter)
10. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
This is a New Matter rejection.
The instant amended claims 7, 11 and 23-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant did not indicate or point out the support for the subject matter that is recited/claimed in the amended claims filed on 05/14/2026.
Claim 7: wherein the device has a limit of detection about 0.015-0.09 fg of the glvcoprotein gD2 per mL.
Claim 11: using polvethylenimine (PEI).
Claim 23: wherein the chitosan is present in the membrane layer in an amount of about 0.1 to 1%m/v of the membrane layer.
Claim 24: wherein the chitosan is present in the membrane layer in an amount of about 0.25 to 0.75% m/v of the membrane layer.
Therefore, the subject matter as recited above in the amended claims 7, 11 and 23-24 is constitutes new matter. See MPEP 608.04 and MPEP 2163.
Claim Interpretation (modified)
11. 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 instant claims 7 is interpreted to be directed to a device for assessing the presence of herpes simplex virus (HSV) in a biological sample comprising:
a substrate that includes a top surface and a back surface; and,
an electrode on the top surface of the substrate, wherein the electrode is functionalized with a detection moiety that binds HSV glycoprotein gD2, and the detection moiety is immobilized on the electrode via an amide bond; and, a membrane layer comprising chitosan on the electrode, wherein the device has a limit of detection about 0.015-0.09 fg of the glycoprotein gD2 per mL of the biological sample containing the HSV, and wherein the device retains at least 60% of its original sensitivity following storage at 40C for 48 hours.
According to the instant specification a substrate that includes a top surface and a back surface is comprised of bacterial cellulose membrane.
The instant claims 7-9 and 11 are directed to a device comprising a graphene electrode to which a binding or capturing or detecting moiety, Nectin-1 receptor or a HSV gD2 specific antibody is immobilized to detect and quantify presence of HSV in a biological sample. Based on the specification, the biosensor is impedimetric biosensors enabled for electrochemical diagnostic comprising detector moiety or binding moiety Nectin-1 receptor or a HSV gD2 specific antibody.
The instant claims 23-24 is directed to the device according to claim 7, wherein the chitosan is present in the membrane layer (for claim 23 in an amount of about 0.1 to 1% m/v or for claim 24 in an amount of about 0.25 to 0.75% m/v, respectively) of the membrane layer.
Claim Rejections - 35 USC § 103 (modified)
12. 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.
13. Claims 7-9, 11 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Afsahi et al 2018 (Biosensors and Bioelectronics 100 (2018) 85–88), and further in view of Peña‑Bahamonde et al 2018 (J Nanobiotechnol (2018) 16:75), Gomes et al 2020 (Electrochimica Acta 349 (2020) 136341), Torres et al 2020 (Med Devices Sens. 2020;3:e10102), Bertucci et al 2003 (Journal of Pharmaceutical and Biomedical Analysis 32 (2003) 697-706), Giovine et al 2011 (PLoS Pathog. 2011 Sep;7(9): e1002277), Bhattarakosol et al 1990 (Arch Virol (1990) 115:89-100), Young-Sook et al 2001 (J. Microbiol. Biotechnol, 20021, 11(2), 173-178), Staser et al 2017 (WO2017066268A1, 04/20/2017), Vermisoglou et al 2020 (Biosensors and Bioelectronics 166 (2020) 112436), Ayyub et al 2016 (US20160168613A1, 06/16/2016), Payne et al 2019 (Sci Rep 9, 13720, 2019), Mattioli et al 2020 (Microchimica Acta, 187(6), 318), Zeng et al 2016 (J. Nanosci. Nanotechnol. 2016, Vol. 16, No. 7) and Monosik et al 2012 (Journal of Clinical Laboratory Analysis 26: 22–34, 2012).
Claims 7-9, 11 and 23-24: Afsahi et al 2018 is in the viral antigen detection biosensor device art and teaches a novel portable graphene-based biosensor device enabled with a highly specific immobilized monoclonal antibody (detection moiety) for early detection of Zika virus NS1 antigen in a clinical sample from an infected human subject (See, abstract, entire article and Figures, supplementary data). Afsahi et al 2018 teaches graphene biosensor chip and antibody is immobilized on graphene chip along the PEG block, the antibody forms the dielectric in a liquid gated transistor with a graphene channel (See figure 1 and associated legend). The biosensor chips were then functionalized with the target sensing antibody, anti-Zika NS1 mouse mAb 6B1 (See, page 86 col 2 section 2.3.). The biosensor candidate graphene is a single layer, two-dimensional sheet of hexagonally arranged carbon atoms. The two-dimensional graphene material sheets every atom in a graphene is in direct contact with its environment and responds to electrostatic fluctuations, making it an ideal candidate for sensing applications and thus teaches instant claim 7 limitation a substrate that includes a top surface and a back surface (See, page 85 col 2). Graphene biosensor chips are read using the commercial Agile R100 system, the graphene biosensor chips are inserted into an electronic reader that applies a source-drain voltage across the graphene channel and a gate voltage between the applied liquid and the drain electrode of the graphene. There are 2 read-out channels available: the I-Response (current through the channel) and the C-Response (capacitance of biosensor to the liquid). In this study, the C-Response channel is used. Control of the system, as well as data readout is performed via the Agile Plus software, which is run on a PC attached to the system via USB (See page 86 col 1-2, page 87 Fig 1b). NHS amino or amine surface chemistry was used to build sensor chips ready for protein attachment (See, page 86, col 2). Afsahi et al 2018 teaches use of polyethylene glycol (PEG) as an effective blocker against non-specific interactions in general and specifically when covalently attached to graphene devices. Residual active NHS groups were first quenched using 3 mM amino-PEG5-alcohol (amino-PEG) pH 7.4 before a final quench with 1 M Ethanolamine pH 8.5 (See, page 86-87, section 2.3 Protein Immobilization). Biosensor chips are fabricated photolithography and plasma enhanced CVD is used to pattern and passivate graphene with Ti/Pt leads on 6” silicon wafers (See, page 86, section 2.1 Graphene biosensor fabrication) and the drain electrode of the graphene (See, page 86, col 2 para 1).
Afsahi et al 2018, as recited supra teaches a device (a biosensor comprising device) to detect Zika virus antigen sensed by a specific binding moiety, a monoclonal antibody, however, does not teach the claimed device comprising a substrate on which the electrode is mounted, and does not teach an electrode coated with binding moiety or antibody specifically to detect instant claim 7 HSV viral glycoprotein D (gD), the detection moiety (e.g. antibody) is immobilized on the electrode via an amide bond; and a membrane layer comprising chitosan on the electrode, sensitivity detection limit and storage at 40 C.
Peña‑Bahamonde et al 2018 teaches recent advances in graphene‑based biosensor technology comprising Graphene–Nafion composite film with applications in life sciences including pathogen detection such as viruses (Zika virus, Dengue virus, Rotavirus) and bacterial pathogen (E. coli) detection using specific antibody. Peña‑Bahamonde et al 2018 teaches Graphene cellulose nanopaper immunosensor design (See, Table 1) or Graphene cellulose microfiber immobilization platform for the electrode (See, Table 4) (See, abstract, page 2 Fig 1, page 4 col 2 para 2, Table 2, entire article). Peña‑Bahamonde et al 2018 teaches added limitation the detection moiety is immobilized on the electrode via an amide bond by disclosing primary amine group from the antibody (antibody reads on detection moiety) forms an amide bond with the carboxyl groups on the Graphene Oxide surface, this process can form conjugates between two different molecules with an amide group (see, 4 col 1 para 2). Peña‑Bahamonde et al 2018 teaches graphene antibody-based nanosensor for detection of influenza virus and Hepatitis C virus antigens (See, Table 1) that has Chitosan (e.g. Graphene oxide-MB–chitosan for influenza virus antigen detection). Peña‑Bahamonde et al 2018 teaches the sensitivity of detection for Hepatitis C virus antigen 3 fg/mL (See, Table 1).
Vermisoglou et al 2020 is in the art and teaches human virus detection with graphene-based materials and disclosed that enzymes and proteins can be immobilized onto graphene both covalently and noncovalently. Among the advantages of immobilized enzymes are their thermal and storage stability and easy separation from reaction mixtures (See, page 9, col 1 para 4).
Morales-Narváez et al 2017 is in the art and teaches Graphene-Based Biosensors: Going Simple, Biosensing has become an important approach within these technologies, particularly those biosensors integrating highly desirable characteristics such as specificity (suitably identifying the target analyte), high sensitivity (determining low levels or the lack of the analyte), fast results (from minutes to hours), extended shelf life, and easy-to-operate
Capabilities (see, Introduction page 1 col 1).
Ayyub et al 2016 (US20160168613A1) is in the art and teaches biosensor comprising device and methods of using device for detection of aminoacidopathies. The biosensor is at least 70% biologically active after about 30 days in storage at 40 C (see, abstract, claim 7).
The instant claim 7 limitation, a substrate that includes a top surface and a back surface is taught by disclosures of Gomes et al 2020, Torres et al 2020, and Peña‑Bahamonde et al 2018 that teaches bacterial cellulose membrane comprising nanofibers and small pore size mesh comprised in a biosensor design (See, entire articles by Gomes et al 2020 and, Torres et al 2020, and Peña‑Bahamonde et al 2018 - table 1, table 4).
Bertucci et al 2003 is in the art and teaches optical biosensor in studying herpes simplex virus glycoprotein D binding to target binding moiety nectin-1 receptor immobilized on the surface of the biosensor cuvette, bearing a carboxymethyl dextran layer. The immobilized receptor cuvette was then used for the binding experiments of the two glycoproteins. Bertucci et al 2003 teaches the binding of two recombinant forms of HSV glycoprotein D, gD(Δ290-299t) and gD(305t), and a recombinant form of the human cellular receptor for HSV, nectin1-Fc, by using an optical biosensor. The binding studies between soluble gD and members of the nectin family of cellular receptors. Comparative binding studies showed that despite the high level of conservation, human and murine nectin-1 receptors differ with respect to the binding properties to HSV virions and gD. HSV cellular receptors, i.e. human and murine nectin1, have been immobilized on the surface of the biosensor (See, abstract, entire article).
Giovine et al 2011 teaches the structure of Herpes Simplex virus glycoprotein D bound to the Human Receptor Nectin-1, the cell adhesion molecule nectin-1 (HveC, CD111) is the primary receptor for HSV-1 and HSV-2 on neurons, keratinocytes and epithelial cells (See, abstract, page 1).
Bhattarakosol et al 1990 teaches two monoclonal antibodies that specifically bind to HSV-2 glycoprotein gD2 (See, abstract, Fig 1, lands 5-6, table 2 Mabs gF-105 and gD106, see entire article).
Young-Sook et al 2001 teaches a monoclonal antibody SKS2v that recognizes or bind to glycoprotein D antigen of HSV-2 in western blot and sandwich ELISA, and immunofluorescence assay (See, abstract, page 176 Fig. 3 lane C, page 177 Fig. 4).
Claim 11: Staser et al 2017 (WO2017066268A1) teaches added limitation of instant claim 11, wherein the detection moiety is immobilized on the electrode using polyethylenimine (PEI) by disclosing a supercapacitor-based biosensor for use in detecting a biomarker comprising: an electrode coated with a nanocomposite film including a nanostructured carbon material (e.g. graphene oxide) and a polymer (e.g. polyethylenimine) containing amine functional groups to form a coated electrode wherein the coated electrode is functionalized with an antibody capable of binding with the biomarker (e.g. apolipoprotein), the nanocomposite film includes chitosan, wherein the antibody is an anti-apolipoprotein antibody (See, abstract, claims 1-19).
Claims 23-24: Payne et al 2019 is in the art and teaches flexible biosensors with a sensing mechanism immobilized by the polymer chitosan with carbon (graphene) nanotubes, , 0.1% chitosan, 0.6% chitosan, 1% chitosan (1% chitosan reads on 1% m/v Chitosan) use to fabricate the biosensor (See, page 8, entire article).
Zeng et al 2016 is in the art and teaches carbon nanotube-graphene nanosheet-Chitosan-1-Butyl-3-Methylimidazolium Hexafluorophosphate nanocomposites and gold nanoparticle-Thionine for electrochemical detection of cytomegalovirus phosphoprotein (Herpes virus). Gold nanoparticles were immobilized on the modified electrode and incorporated into layers of the polymeric redox mediator thionine that comprised Chitosan 1% (m/v), the monoclonal antibodies against cytomegalovirus phosphoprotein PP65 were immobilized on the surface via an amine-gold interaction (See, abstract, page 6727 col 2 last para, entire article).
Mattioli et al 2020 is in the art and teaches screen-printed disposable electrodes using graphite-polyurethane composites modified with magnetite and chitosan-coated magnetite
nanoparticles for voltammetric epinephrine sensing and disclosed 1% (m/v) chitosan to fabricate the biosensor (see, page 3, entire article for Chitosan).
Therefore, it is known in the art that Chitosan solutions with concentrations around 0.5% to 1.0% (m/v) are used to fabricate electrochemical biosensor electrodes for detection of biomarker(s) (reads on virus or viral antigen) detection. Chitosan acts as a biocompatible cationic polymer matrix that firmly traps antibodies, (like graphene or carbon nanotubes) onto the electrode surface via its reactive amino groups.
Additionally, Monosik et al 2012 teaches Nafion membrane used for coating electrochemical biosensors in clinical diagnosis and the biosensor electrodes that have been constructed with a permselective nafion membrane functionalized graphene nanoplatelets (See, Monosik et al 2012, page 27, col 1 para 3, page 26, para 2).
It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the prior art teachings of Afsahi et al 2018 on a device comprising a biosensor enabled to detect zika virus antigen bound to a specific monoclonal antibody coated on an electrode with the additional teachings of Peña‑Bahamonde et al 2018, Gomes et al 2020, and Torres et al 2020 on bacterial cellulose membrane use in biosensor, and further teachings of Bertucci et al 2003 and, Giovine et al 2011 on Nectin-1 (Nectin-1 receptor) that can bind both HSV-1 and HSV-2 gD that can provide a binding moiety (Nectin-1) to replace anti-Zika virus NS1 antigen Mab to arrive at a biosensor device that can detect both HSV 1 and HSV-2 glycoprotein D antigens (gD1 and gD2) in a sample from a subject or a laboratory cell culture grown HSV-1 and HSV-2 viruses. Alternatively, the teachings of Bhattarakosol et al 1990, and Young-Sook et al 2001 on HSV-2 gD (gD2) specific Mabs can be used to replace the Nectin-1 from the electrode to specifically detect HSV-2 glycoprotein D (gD2), teachings of the additional applied prior arts, as recited supra, on Chitosan % m/v, PEI, sensitivity of detection, shelf-life storage stability of the biosensor electrode to arrive at the invention of claims 7-9, 11 and 23-24. One of ordinary skills in the art would have been motivated to modify the electrode coated with anti-Zika virus antibody comprised in device comprised a biosensor device of Afsahi et al 2018 with additional prior art teachings on Nectin-1 or HSV-2 glycoprotein D specific Mabs to develop a biosensor comprising device directed to detect HSV2 (anti-gD 2 Mab as a binding moiety) or both HSV-1 and HSV-2 (anti-gD Nectin-1 as a binding moiety for both gD1 and gD2) for rapid and sensitive diagnosis and for commercial success. One of the ordinary skills in the art would have been apprised of a reasonable expectation of success to arrive at the invention of claims 7-9, 11 and 23-24 in view of the combined prior art teachings as recited supra and the availability of prior art teachings on graphene electrode-based biosensor devices in the art 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 claimed inventions of claims 7-9, 11 and 23-24. The instant claims 7-9, 11 and 23-24 are prima facie obvious over the combined prior art teachings as recited supra. 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).
Response to Arguments
14. Applicant’s arguments with respect to claims 7-12 have been considered but are moot because the new ground of rejection does not rely only on reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Additional teachings and references were applied for the modified office action in this final rejection.
Applicant’s arguments:
Rejections Under 35 U.S.C. § 103: Claims 7-11 stand rejected under 35 U.S.C. § 103 as being unpatentable over Afsahi, et al., Biosensors and Bioelectronics 100 (2018) 85-88 ("Afsahi") in view of Pena-Bahamonde, et al., J Nanobiotechnol (2018) 16:75 ("Pena-Bahamonde"), Gomes, et al., Electrochimica Acta 349 (2020) 136341 ("Gomes"), Torres, et al., Med Devices Sens. 2020;3:e10102 ("Torres"), Bertucci, et al., Journal of Pharmaceutical and Biomedical Analysis 32 (2003) 697-706 ("Bertucci"), Giovine, et al., PLoS Pathog. 2011 Sep;7(9): e1002277 ("Giovine"), in view of Bhattarakosol, et al., Arch Virol (1990) 115:89-100 ("Bhattarakosol"), and Young-Sook, et al., J. Microbiol. Biotechnol, 20021, 11(2), 173-178 ("Young-Sook").
Claim 12 was separately rejected for alleged obviousness over Afsahi in view of Pena-Bahamonde, Gomes, Torres, Bertucci, Giovine, Bhattarakosol, and Young-Sook, as allegedly evidenced by Liu, J. Am. Chem. Soc. 1997, 119, 8720-8721 ("Liu"), Fissell, et al., Journal of Membrane Science 326 (2009) 58-63 ("Fissell"), and Monosik, et al., Journal of Clinical Laboratory Analysis 26: 22-34 (2012) ("Monosik").
However, the cited references do not present a prima facie case of obviousness. For
example, the Office has not alleged, nor is it the case, that the cited references disclose or suggest a device as claimed, which includes, inter alia, an electrode, a detection moiety that is
immobilized on the electrode via an amide bond, and a membrane layer comprising chitosan on the electrode.
Secondary evidence: Moreover, the present inventors have surprisingly discovered that devices having the claimed characteristics can detect HSV glycoprotein gD2 within a biological sample containing HSV at a sensitivity of about 0.015-0.09 fg of the per mL, which represents an extremely high degree of sensitivity. Moreover, it was unexpectedly found that the device retains at least 60%, 70%, 80%, or 90% of its original sensitivity following storage at 4°C for 48 hours. In other words, the present devices provide unexpectedly beneficial results at least with respect to sensitivity and stability.
For at least the preceding reasons, Applicant respectfully submits that withdrawal of the rejections under § 103 is appropriate. See In re Royka, 490 F.2d 981 (C.C.P.A. 1974) (all limitations set forth in a patent claim must be taught or suggested in the prior art to establish a prima facie case of obviousness). See also Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983) ("evidence rising out of the so-called 'secondary considerations' must always when present be considered en route to a determination of obviousness").
In Response: 35 U.S.C. 103 rejection of claims.
Applicant's argument regarding 35 U.S.C. 103 rejection of the claims is not persuasive because the combined prior art teachings has rendered obvious the claims in the prior office action and the applicant’s amended claims regarding the claimed device comprising biosensor to detect and quantify HSV glycoprotein gD2 and thus the claimed sensitivity of detection is inherent. In addition, in view of the combined teachings of the applied prior arts the device comprising the claimed biosensor is reasonably expected to offer the claimed sensitivity of detection of HSV glycoprotein gD2 as recited in the modified office action, and therefore the claimed inventions are obvious, and it is a clear a prima facie case of obviousness.
The arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence, and which must be supported by an appropriate affidavit or declaration.
In Response: Secondary Evidence.
Applicant's argument of “surprising (unexpected result)” of sensitivity of about 0.015-0.09 fg of the per mL to detect HSV glycoprotein gD2 is not persuasive, since the references cited in the modified 35 U.S.C. 103 rejection provide reasonable expectation for achieving the claimed sensitivity what applicant has alleged/argued is surprising/unexpected.
The prior art Peña‑Bahamonde et al 2018 teaches the sensitivity of detection for Hepatitis C virus antigen 3 fg/mL and the teachings are used to modify the primary reference and combined prior art renders obvious the claims and the limitations (see office action above).
In re Schultz: attorney argument is not evidence.
MPEP 2145 Consideration of Applicant's Rebuttal Arguments and Schulze
The arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence, and which must be supported by an appropriate affidavit or declaration.
15. Relevant Prior Arts:
Nicola et al 1998. Monoclonal antibodies to distinct sites on herpes simplex virus (HSV) glycoprotein D block HSV binding to HVEM. J Virol. 1998 May;72(5):3595-601. Monoclonal antibody to gD of HSV-1 is disclosed.
Vermisoglou et al 2020. Human virus detection with graphene-based materials. Biosens Bioelectron. 2020 Oct 15; 166:112436. Different types of graphene-based sensors available for virus detection, including, e.g., photoluminescence and colorimetric sensors, and surface plasmon resonance biosensors. Various strategies of electrochemical detection of viruses based on antigen-antibody interactions are reviewed.
Garcia et al 2020. Impedimetric Biosensor for Bovine Herpesvirus Type 1-Antigen Detection. Electroanalysis 2020, 32, 1100 – 1106.
Siuzdak et al 2019. Biomolecular influenza virus detection based on the electrochemical impedance spectroscopy using the nanocrystalline boron-doped diamond electrodes with covalently bound antibodies. Sensors & Actuators: B. Chemical 280 (2019) 263–271. (Year: 2019).
Nguyen et al 2012. Electrochemical impedance spectroscopy characterization of nanoporous alumina dengue virus biosensor. Bioelectrochemistry 88 (2012) 15–21. (Year: 2012)
Conclusion
16. No claim is allowed.
17. 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).
18. 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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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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