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 .
Priority
2. This application is a section 371 National Stage Application of International Application No. PCT/US2021/029384, filed April 27, 2021, and published as WO 2021/222237 A1 on November 4, 2021, in English, which claims priority to US provisional patent application Serial No. 63/018,127, filed April 30, 2020.
Election/Restrictions
3. Applicant’s election without traverse of Group II claims 13,15,17-18,20,23,26 and 28 in the reply filed on 09/26/2025 is acknowledged.
Status of Claims
4. Claims 1-5, 8-9, 11, 13, 15, 17-18, 20, 26, 28 and 31-34 as amended and filed on 12/08/2025 are pending.
5. Claims 23 is cancelled by the applicant on 12/08/2025.
6. Claims 13, 15, 17-18, 20, 26 and 28 as amended and filed on 12/08/2025 are under examination.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on 10/31/2022 and 02/08/2024 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Withdrawn Objection(s) and/or Rejection(s)
8. Withdrawn claim objection or interpretation according to 35 U.S.C. 112(f) in view of amended claim 13 filed on 12/08/2025 to delete claim limitation: “configured to” in claim 13.
9. Withdrawn claim 13 rejection under 35 U.S.C. 112(a) written description in view of amended claim 13 filed on 12/08/2025.
10. Withdrawn rejection of claims 13 and 17 under 35 U.S.C. 102(a)(1)/ (a)(2) in view of amendment to claim 13 as filed on 12/08/2025.
11. Withdrawn claims 13, 15, 17-18, 20, 26 and 28 rejections under 35 U.S.C. 112(a) enablement requirement in view of amendment to claim 13 as filed on 12/08/2025.
12. Withdrawn claims 13, 15, 17-18, 20, 26 and 28 rejections under 35 U.S.C. 112(a) written description in view of amendment to claim 13 as filed on 12/08/2025.
13. Withdrawn claims 13, 15, 17-18, 20 and 23 (claim 23 is cancelled) rejections under 35 U.S.C. 112(b) in view of amendment to claim 13 as filed on 12/08/2025.
Broadest Reasonable Interpretation (Amended)
14. 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 claim 13 is interpreted to be directed to a method of detecting a viral infection in an individual comprising analyzing the viral infection in the individual through a virus detection system embedded in a facemask, wherein the individual wears the facemask for a time period, wherein the test region is placed to receive the respiratory droplets and/or aerosol particles discharged from the individual, the virus detection system comprising a test region and virus binding molecules, wherein the virus detection system detects one or more selected respiratory viruses bound to the virus binding molecules in the test region. The claim 13 is interpreted to detect one or more respiratory viruses exhaled by an infected individual wearing the facemask (internal assay). The claim 13 is interpreted to detect any one or more respiratory virus or a respiratory viral infection in an individual wearing the facemask and discharging a respiratory virus as droplet. The claimed facemask does not comprise a full detection system that can provide the result of the respiratory virus detection from the exhaled droplet when an individual is wearing the facemask. The facemask comprises a device or a system with specific antibody to a specific exhaled respiratory virus in a droplet. After collection of the sample the device is separated from the facemask and a virus detection assay is performed. The assay could be an enzyme immunoassay (EIA), an enzyme-linked immunosorbent assay (ELISA) system, a lateral flow immunochromatographic assay (LFIA), a three-dimensional paper-based assay for detection of an antigen, e.g. SARS-CoV-2 (Specification para [0040]).
The dependent claims 26 and 28 are interpreted to be directed to detect a SARS-CoV-2 virus (Specification para [0040]).
Claim Rejections - 35 USC § 103 (Amended)
15. 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.
16. Claims 13, 15, 17-18, 20, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kanzer 2007 (US20070199567A1 published 08/30/2007), and further in view of Matsuda et al 2020 (US20100159615A1 published 06/24/2010), Schade et al 2005 (ATLA 33, 129–154, 2005), and da Silva et al 2010 (Veterinary Immunology and Immunopathology 135 (2010) 173–180), Le et al 2017 (Anal. Chem. 2017, 89, 6781−6786), Kim et al 2019 (Analyst, 2019, 144, 2460), Collins et al 2020 (Allen Institute News, published online 04/23/2020), Leung et al 2020 (Nature Medicine, vol 26, 676, May 2020 p. 676–680), Chen et al 2020 (CN111024954A published 04/17/2020).
Claim 13: Kanzer 2007 (US20070199567A1) teaches a method of detecting a viral infection in an individual comprising analyzing the viral infection in the individual through a virus detection system embedded in a facemask by disclosing the biosampling material may comprise a uniquely identifiable preprinted material or strip separate from the mask that is capable of being affixed to the interior of a wide variety of face masks. Such material should be affixed in a fashion as to avoid the potential for inhalation by the wearer while still allowing convenient removal, collection and uniformity to facilitate rapid automated testing and analysis (See, para [0091], [0058], claim 2 (c), (i)- limitation (iii)-(iv), claim 8 ( e), claim 8 (s), claim 8 (u)), wherein the individual wears the facemask for a time period, wherein the test region is placed to receive the respiratory droplets and/or aerosol particles discharged from the individual, the virus detection system comprising a test region and virus binding molecules, wherein the virus detection system is configured to detect one or more viruses (See, US20070199567A1: claims 1-25, abstract, para [0007], [0050], [0058], [0098], [0003]-[0005], [0033], Figures 1-12; entire prior art US20070199567A1 ). Kanzer 2007 teaches the facemask comprise immunoassay device capable of immediately identifying and characterizing exhaled particles of the wearer that selectively bind to antibodies or other proteins selective for one or more infectious diseases of interest (See, para [0095], claim 4). Kanzer 2007 teaches viruses e.g. SARS, and avian influenzas including influenza A (H5N1) and H5N9 (See, para [0033], [0003]-[0005]), a expiratory droplet collection device such as a expiratory droplet collection strip or face mask (See, para [0077]), wearing of expiratory droplet collection devices (para [0062]), droplet collection devices and methods to detect and control airborne communicable diseases utilizing rfid, a filtering face mask that comprises: (a) a mask body; and (b) at least one diagnostic device for identifying whether the wearer of the mask is infected with a contagious disease (See, abstract, claims 1-25), methods and devices for collecting respiratory droplets, improve compliance with infection control procedures (See, para [0083], claim 10).
Kanzer 2007 (US20070199567A1) teaches all the limitations of instant claim 13 except “virus binding molecules within the test region wherein the virus binding molecules are avian antibodies”, and detection of more than one selected virus bound to the virus binding molecule.
Matsuda et al 2020 is in the antigen immunoassay art and teaches avian antibodies by disclosing an immunological detection method using an avian antibody, comprising suppressing a non-specific reaction caused by using an avian antibody. An immunological detection method comprising detecting a target substance in a sample from a mammal using an avian antibody, characterized in that the use of the avian antibody is suppresses a non-specific reaction in an immunoassay directed to detect a target substance.
Schade et al 2005 is in the art and reviewed and teaches production of chicken egg yolk antibodies (IgY-technology) in immunodiagnostics, IgY antibodies are used successfully in immunohistochemistry for the detection of antigens of virus (p.144, col 2 para 2), antibodies against the E7 oncoprotein of human papilloma virus type 16 (HPV16) in rabbits and chickens. Mapping the epitopes with eight HPV16E7 peptides revealed that the chicken Abs reacted with all eight peptides,
whereas the rabbit antibodies recognized only two epitopes (See, p.138, col 2, para 2).
da Silva et al 2010 is in the art and teaches avian (chicken) antibody IgY as a promising antibody for use in immunodiagnostic assay the utility of IgY in many immunological assays without loss of specificity and sensitivity (See, abstract, p. 178, col 2, para 5 in concluding remarks). Chicken antibodies exhibit high avidity (10⁹ L/mol) even after the first immunization. In order to reach similar avidity values (10¹⁰ L/mol), sheep must receive four boosters (See, p. 177, para 3).
Claim 17 (dependent on claim 13): Kanzer 2007 (US20070199567A1) teaches the added limitation of instant claim 17 (dependent on claim 13), wherein the individual wears the facemask during an activity is taught by the disclosure “face masks that may be collected upon exit of a hospital setting by a healthcare worker, patient or visitor” (See, para (0063]).
Le et al 2017 is in the art teaches a lateral flow immunoassay for multiplex strain specific influenza virus detection based on dual recognition elements (See, abstract, Fig 1, entire article).
Kim et al 2019 is in the art teaches a new point-of-care test for the diagnosis of viral infectious diseases based on multiplex lateral flow immunoassays based on antibodies that specifically capture or bind to the viruses in a sample (See, abstract, Figure 1, entire article).
It would have been obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to modify the prior art teachings of Kanzer 2007 with additional teachings of Matsuda et al 2020 (US20100159615A1), Schade et al 2005, and da Silva et al 2010, Le et al 2017 and Kim et al 2019 to arrive at the invention of claims 13 and 17. One of the ordinary skills would have been motivated to develop a method of detecting a viral infection in an infected individual wearing a facemask, inter alia, fitted with a virus antigen detection immunoassay device (a lateral flow immunoassay device) as recited supra to take an advantage of avidity and reduction in non-specific reactivity of mammalian origin antibodies as compared to avian antibody against target antigen or a respiratory viral pathogen (avian origin antibodies) and for commercial success of the claimed facemask. There would be a reasonable expectation of success given the applied prior art teachings 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 invention as claimed in claims 13 and 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).
The combined teachings of Kanzer 2007, Matsuda et al 2020, Schade et al 2005, da Silva et al 2010, Le et al 2017 and Kim et al 2019 teaches instant claim 13 and 17, however, does not explicitly teach the added limitations of claim 15 (time period), claim 18 (test region provides a positive indicator signal), claim 20 (substrate addition), claim 26 (SARS-CoV-2), claim 28 (binding molecule binds to spike of SARS-CoV-2).
Claim 15: The added limitation of claim 15 is taught by Kanzer 2007, and Leung et al 2020.
Kanzer 2007 (para [0003]) disclosed a method of operating a workplace comprising providing a facemask comprising a viral detection system, wherein individuals working in the business wear the face mask during the work day and wherein the viral detection system in the facemask is evaluated for the presence of the virus after a time period, wherein the virus detection system is configured to detect one or more viruses. Leung et al 2020 is in the art and teaches detection of respiratory virus shedding in exhaled breath and efficacy of face masks using RT-PCR and discloses participants were compensated for each 30-min exhaled breath collection (See, p. 681, col 1, methods, para 2).
Claims 18, 20 and 26: Chen et al 2020 (CN111024954A) teaches the added limitations of claim 18, 20 and 26.
Chen et al 2020 teaches a lateral flow immunoassay, a colloidal gold immunochromatographic device for joint detection of a novel coronavirus COVID-19 antigen (SARS CoV-2) and a novel coronavirus COVID-19 antibody and a use method thereof, which can accurately judge the immunological reaction state of an organism by simultaneously detecting the novel coronavirus COVID-19 antigen (See, abstract, claims 1-10, Figure 1-2, claim 10 color development, positive test detection and control line); the COVID-19 antigen detection test strip comprises a first sample pad, a first combination pad, a first reaction pad and a first water absorption pad which are connected in sequence; the first binding pad is coated with a novel coronavirus NP protein monoclonal antibody marked by colloidal gold and a rabbit IgG antibody marked by colloidal gold, the first reaction pad is sequentially provided with a first detection line and a first quality control line along the flow direction of a sample, and the first detection line is coated with the novel coronavirus NP protein monoclonal antibody (See, claim 1); judging whether the sample contains the novel coronavirus COVID-19 antigen and the novel coronavirus COVID-19 antibody according to the color development conditions of the detection line and the quality control line, wherein the judgment method comprises the following steps: for the COVID-19 antigen detection test strip, 1) positive: the first quality control line and the first detection line both present red bands, which indicates that the sample contains the novel coronavirus COVID-19 antigen; 2) negative: the first quality control line presents a red strip, and the first detection line does not present a red strip, which indicates that the sample does not contain the novel coronavirus COVID-19 antigen (See, claim 10).
Chen et al 2020 does not teach as facemask fitted with a lateral flow immunoassay device.
Collins et al 2020 disclosed to public a concept and design for developing a diagnostic face mask that signals if the wearer is infected with COVID-19 (See, PDF printout).
It would have been obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to modify the combined prior art teachings of Kanzer 2007, Matsuda et al 2020, Schade et al 2005, da Silva et al 2010, Le et al 2017 and Kim et al 2019 with the additional teachings of Collins et al 2020, Leung et al 2020, and Chen et al 2020 (the immunoassay device and SARS COV-2 COVID-19 virus antigen) as recited supra to arrive at the inventions of claims 15, 18, 20, and 26. One of the ordinary skills would have been motivated to develop a method of detecting a viral infection in an infected individual wearing a facemask, inter alia, fitted with a virus antigen detection immunoassay device (a lateral flow immunoassay device) similar to the one taught by Chen et al 2020 as recited supra. The motivation would be to develop a facemask design, and a product integrated/fitted with a virus detection assay device or a detection system to eliminate invasive collection of respiratory samples, capture exhaled respiratory virus , a SARS CoV-2 COVID-19 virus, from an infected individual, protect surrounding environment and people by wearing the mask and mitigate transmission of a virus (e.g. SARS CoV-2 virus) or an alternative claim interpterion for detection of a virus in an environment surrounding to an individual wearing the mask to enhance/increase sensitivity of the assay and for commercial success of the facemask. There would be a reasonable expectation of success given the applied prior art teachings in the art to render the claims obvious 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 as claimed in claims 15, 18, 20 and 26. 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).
17. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Kanzer 2007 (US20070199567A1 published 08/30/2007), Matsuda et al 2020 (US20100159615A1 published 06/24/2010), Schade et al 2005 (ATLA 33, 129–154, 2005), and da Silva et al 2010 (Veterinary Immunology and Immunopathology 135 (2010) 173–180), Le et al 2017 (Anal. Chem. 2017, 89, 6781−6786), Kim et al 2019 (Analyst, 2019, 144, 2460), Collins et al 2020 (Allen Institute News, published online 04/23/2020), Leung et al 2020 (Nature Medicine, vol 26, 676, May 2020 p. 676–680), Chen et al 2020 (CN111024954A published 04/17/2020) as applied to claim 13 (claims 13, 15, 17-18, 20, and 26) above, and further in view of Chen et al 2020 ( Cellular & Molecular Immunology (2020) 17:647 – 649, published 20 April 2020).
Claim 28 (dependent on claim 13): The combined teachings of the prior art by Kanzer 2007, Matsuda et al 2020, Schade et al 2005, da Silva et al 2010, Le et al 2017 and Kim et al 2019as applied above render the claim 13 obvious, however, does not teach the added limitations of claim 26 wherein the virus is severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
Chen et al 2020 is in the art and teaches human monoclonal antibodies that bind to SARS-CoV-2 spike protein Specificity of mAbs (311mab–31B5, −32D4 and −31B9 clones) to SARS-CoV-2 RBD protein by ELISA (See, Fig. 1 f and legend).
It would have been obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to modify the combined prior art teachings of Kanzer 2007, Matsuda et al 2020, Schade et al 2005, and da Silva et al 2010 with the additional teachings of Chen et al 2020 on monoclonal antibodies binding to spike protein of SARS CoV-2 virus to arrive at the invention of claim 28 as recited supra. One of the ordinary skills would have been motivated to develop a method of detecting a viral infection in an infected individual wearing a facemask, inter alia, fitted with a virus antigen detection immunoassay device (a lateral flow immunoassay device) as recited supra to develop a method for detection of spike protein of SARS CoV-2 virus in infected individual and for commercial success of the facemask. There would be a reasonable expectation of success given the applied prior art teachings 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 invention as claimed in claim 28. 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
18. Applicant’s arguments with respect to claims 13, 15, 17-18, 20, 26 and 28 have been considered but are not found persuasive in light of the above modified rejection in addressing the amended claim 13 and in light of the following.
Applicant’s Argument: Applicant argues/remarks disagreement over objection and rejection of claims 13, 15, 17-18, 20, 23, 26 and 28 under 35 USC 112(a) or 35 USC 112(b) or 35 USC 112(f).
In Response: Rejection of claims 13, 15, 17-18, 20, 23 (claim 23 is cancelled), 26 and 28 under 35 USC 112 and objection of claim 13 under 35 USC 112(f) is withdrawn in view of applicant’s amendment of claim 13 as recited supra.
Applicant’s Argument: Applicant argues/remarks disagreement over rejection of claims 13 and 17 under 35 USC 102.
In Response: Rejection of claims 13 and 17 under 35 USC 102 is withdrawn in view of applicant’s amendment of claim 13 that incorporated additional claim limitations on avian antibody and more than one virus detection as recited supra.
Applicant’s Argument: Applicant argues/remarks disagreement over rejection of claims 13, 15, 17-18, 20, 26 and 28 under 35 USC 103.
In Response: In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, applicant’s arguments over rejection of claims 13, 15, 17-18, 20, 26 and 28 under 35 USC 103 have been considered, however, were not found persuasive in view of the of the Kanzer teaching the use of a face mask comprising an embedded assay for purposes of achieving viral screening within the instantly claimed scope. As pointed out in the above obviousness rejections, any differences (e.g. use of an antibody of avian species origin) was disclosed/suggested by the secondary reference(s) as an obvious design choice. Applicant’s argument of the references, taken separately (e.g. Leung) reference fails to appreciate the combined teaching of these references with the primary reference teaching. The secondary references are analogous to the Kanzer reference and suggest obvious design modifications.
The rejection of the claims 13, 15, 17-18, 20, 26 and 28 under 35 USC 103 are maintained as recited supra.
19. Relevant Prior Arts:
Tian et al 2020. Potent binding of 2019 novel coronavirus spike protein by a SARS coronavirus-specific human monoclonal antibody. Emerg Microbes Infect. 2020 Feb 17;9(1):382-385.
Huynh et al 2008. A New Method for Sampling and Detection of Exhaled Respiratory Virus Aerosols. Clinical Infectious Diseases 2008; 46:93-95.
Conclusion
20. No claim is allowed.
21. 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).
22. 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.
23. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Quality Assurance Specialist, Art Unit 1600