DETAILED CORRESPONDENCE
Application 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 .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
3. Applicant’s amendment to the claims filed on 04/30/2026 in response to the Final Rejection mailed on 02/12/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
4. Claims 19-25, 27-33, and 36-40 are pending.
5. Claims 19-25, 27-33, and 36-40 stand withdrawn pursuant to 37 CFR 1.142(b).
6. Applicant’s remarks filed on 04/30/2026 in response to the Final Rejection mailed on 02/12/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Claim Objections
7. The objection to claims 39 and 40 is withdrawn in view of applicants’ amendment to the claims.
Claim Rejections - 35 USC § 112(a)
8. The new matter rejection of claims 1-5, 8-9, and 12-18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicants’ amendment to the claims to recite “woven fibrous material” and “thermally bonded or mechanically bonded nonwoven fibrous material”.
Claim Rejections - 35 USC § 103
9. The rejection of claims 1-5, 8, 15, and 17-18 under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) is withdrawn in view of applicants’ amendment to the claims to recite “gold particles consisting of gold atoms”.
10. The rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) as applied to claims 1-5, 8, 15, and 17-18, and further in view of Amorosi et al. (WO 2022/064353, priority to 09/22/2020; cited on PTO-892 mailed on 08/21/2025) is withdrawn for the reasons set forth above regarding Matsumura et al. and Chung et al.
11. The rejection of claims 12-14 and 16-17 under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) as applied to claims 1-5, 8, 15, and 17-18, and further in view of Kim et al. (Nature Biotechnology, 2019; cited on PTO-892 mailed on 08/21/2025) and Nguyen et al. (Nature Biotechnology, published online 06/28/2021; cited on IDS filed on 10/03/2022) is withdrawn for the reasons set forth above regarding Matsumura et al. and Chung et al.
12. Claims 1-5, 8, 15, and 17-18 are newly under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) and Russell et al. (US Patent Application Publication 2009/0230322; cited on IDS filed on 10/21/2025). This new grounds of rejection is necessitated upon applicants’ amendment to the claims to recite “gold particles consisting of gold atoms”.
13. As amended, claims 1-5, 8, 15, and 17-18 are drawn to a diagnostic system, comprising: at least one layer of a woven fibrous material or a thermally bonded or mechanically bonded fibrous nonwoven material; a color changing moiety immobilized on or bound to the at least one layer of a woven fibrous material or a thermally bonded or mechanically bonded nonwoven fibrous material, wherein the color changing moiety is consists of gold particles, at least one linker linked to the gold particles consisting of gold atoms, an anchor protein linked to the at least one linker, and at least one antibody or antibody fragment conjugated to the anchor protein, wherein the at least one antibody or antibody fragment as an affinity for a viral antigen of interest, and wherein the color changing moiety changes color when the at least one antibody or antibody fragment binds to the viral antigen of interest.
14. With respect to claim 1, Matsumura et al. teach a diagnostic system for quantitation of analyte such as a protein or viral protein comprising a color changing moiety position immobilized at least one layer of material such as a cellulose filter paper, non-woven, cloth, cloth, cellulose acetate, epoxy resin ((interpreted as thermally bonded nonwoven material) wherein the color changing moiety is comprises of a gold composite and at least one antibody that has an affinity for a viral antigen of interest and wherein the color changing moiety changes color when the at least one antibody or antibody fragment binds to the viral antigen of interest [see paragraphs 0023-0034, 0073-0077, 0085, 0100, 0104, 0114, 0125; Figure 2]. The teachings of a resin-gold composite is given the interpretation of a “gold particle”.
With respect to claim 2, Matsumura et al. teach the diagnostic system wherein the gold particles are gold nanoparticles [see paragraphs 0011, 0073-0077].
With respect to claim 8, Matsumura et al. teach the diagnostic system wherein the antigen of interest can be proteins that fall within the claimed molecular weight range [see paragraph 0127].
With respect to claims 15 and 17, Matsumura et al. teach the diagnostic system wherein the at least one layer is cellulose filter paper, non-woven cloth, cloth and cellulose acetate [see paragraph 0100]. The teaching of a non-woven cloth or cloth taught by Matsumura et al. is interpreted as “configured as a wipe”, as a cloth can be reasonably interpreted as something that can be used to wipe a surface, which is a substrate other than animal skin.
With respect to claim 18, Matsumura et al. teach the diagnostic system wherein the at least one layer is cellulose filter paper, non-woven cloth, cloth and cellulose acetate [see paragraph 0100]. The teaching of a non-woven cloth or cloth taught by Matsumura et al. is interpreted as “configured as a surface cover”, as a cloth can be reasonably interpreted as something that covers a surface.
However, Matsumura et al. does not teach the diagnostic system of claim 1 of at least one linker linked to the gold particles, wherein the gold particles consisting of gold atoms, an anchor protein linked to the at least one linker, and at least one antibody or antibody fragment conjugated to the anchor protein; the diagnostic system of claim 3, wherein the at least one linker has a sulfhydryl moiety and a carboxylic moiety; the diagnostic system of claim 4 wherein the at least one linker is 11-mercaptoundecanoic acid (MUDA) or cysteine (Cys); the diagnostic system of claim 5, wherein the anchor protein is selected from protein A, protein A ZZ domain, protein G, protein L, and fragments thereof.
Chung et al. teach nanogap sensors for the research of single molecules, nanoparticles, protein and DNA comprising gold nanoparticles linked to an anchor protein that is conjugated to an antibody, wherein the anchor protein is a modified protein-G linker tagged with three cysteines as a linker [see Abstract; paragraph 0080]. Chung et al. teach the advantage of these sensor is that manufacturing is simple and can be produced in large quantities making it possible to form various electrodes, measure the electrical characteristics of various materials and apply to various sensors [see paragraph 0084].
Russell et al. teach providing particles comprising gold particles either as a metal core or metal oxide bound to fluorescently tagged antibodies for the detection of substance excreted by humans such as a fingerprint, or the bodily fluid itself [see Abstract; Figures 1-2; paragraphs 0001-0002; 0009-0018].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Matsumura et al., Chung et al., and Russell et al. according to the teachings of Chung et al. and Russell et al. to include an anchor protein linking the gold particles of Matsumura et al. to the antibodies because Matsumura et al. teach a diagnostic system for quantitation of analyte such as a protein or viral protein comprising a color changing moiety position on or with at least one layer of fibrous fibers using gold particles and antibodies. Chung et al. teach nanogap sensors for biosensors comprising gold nanoparticles conjugate to antibodies for detection of analytes via a modified protein-G linker that is simple to produce and have a wide range of applications. Russell et al. teach providing particles comprising gold particles bound to fluorescently tagged antibodies for the detection of substance excreted by humans such as a fingerprint, or the bodily fluid itself. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Matsumura et al. and Chung et al. and Russell et al. because Chung et al. acknowledges the wide range of applications of these biosensors and the ease of production and Russell et al. acknowledges the interchangeable use of metal cores such as gold or metal oxides to attach fluorescently tagged antibodies for the detection of substances from human secretions. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
15. Claim 9 is newly rejected under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) and Russell et al. (US Patent Application Publication 2009/0230322; cited on IDS filed on 10/21/2025) as applied to claims 1-5, 8, 15, and 17-18, and further in view of Amorosi et al. (WO 2022/064353, priority to 09/22/2020; cited on PTO-892 mailed on 08/21/2025). This new grounds of rejection is necessitated upon applicants’ amendment to the claims to recite “gold particles consisting of gold atoms”.
16. The relevant teachings of Matsumura et al., Chung et al., and Russell et al. as applied to claims 1-5, 8, 15, and 17-18 are set forth above.
With respect to claim 9, Matsumura et al. teach the diagnostic system wherein the antigen of interest is viral antigen [see paragraph 0127].
However, the combination of Matsumura et al. and Chung et al. do not teach the diagnostic system of claim 9, wherein the antigen of interest is SARS-CoV-2 virus S-protein.
Amorosi et al. teach diagnostic kits based on gold capture nanoparticles and at least one antibody for binding a SARS-CoV-2 virus antigen such as the S-protein [see Abstract; p. 6].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Matsumura et al., Chung et al., Russell et al. and Amorosi et al. for a diagnostic system for detecting the SARS-CoV-2 virus S-protein because Matsumura et al., Chung et al., and Russell et al. teach diagnostic systems based on gold nanoparticles and antibodies for detection of the presence of viruses. Amorosi et al. teach similar systems for detecting the SARS-CoV-2 virus S-protein based on gold nanoparticles. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to substitute the viral antigens of Matsumura et al., Chung et al., and Russell et al. with the SARS-CoV-2 virus S-protein antigen of Amorosi et al. because Amorosi et al. acknowledges that SARS-CoV-2 virus S-protein antigens can be detected using gold nanoparticle-antibody systems. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
17. Claims 12-14 and 16-17 are newly rejected under 35 U.S.C. 103 as being unpatentable over Matsumura et al. (US Patent Application Publication 2017/0168049 A1; cited on PTO-892 mailed on 08/21/2025) in view of Chung et al. (US Patent Application Publication 2009/0215156 A1; cited on PTO-892 mailed on 08/21/2025) and Russell et al. (US Patent Application Publication 2009/0230322; cited on IDS filed on 10/21/2025) as applied to claims 1-5, 8, 15, and 17-18, and further in view of Kim et al. (Nature Biotechnology, 2019; cited on PTO-892 mailed on 08/21/2025) and Nguyen et al. (Nature Biotechnology, published online 06/28/2021; cited on IDS filed on 10/03/2022). This new grounds of rejection is necessitated upon applicants’ amendment to the claims to recite “gold particles consisting of gold atoms”.
18. The relevant teachings of Matsumura et al., Chung et al., and Russell et al. as applied to claims 1-5, 8, 15, and 17-18 are set forth above.
Matsumura et al. teach the diagnostic system wherein the at least one layer is cellulose filter paper, non-woven cloth, cloth and cellulose acetate [see paragraph 0100].
However, the combination of Matsumura et al., Chung et al., and Russell et al. do not teach the diagnostic system of claim 12, wherein the diagnostic system is configured as a face mask wearable by a human or a non-human animal subject; the diagnostic system of claim 13, wherein the diagnostic system is configured as a garment; the diagnostic system of claim 14, wherein the diagnostic system is configured as a bedding cover; and the diagnostic system wherein the wipe is configured for use on animal skin.
Kim et al. teach that wearable biosensors are garnering substantial interest due to their potential to provide continuous, real-time physiological information via dynamic, noninvasive measurements of biochemical markers in biofluids, such as sweat, tears, saliva and interstitial fluid [see Abstract]. Kim et al. further teach wearable garments and patches containing integrated biosensors for the detection of various analytes [see Figure 2].
Nguyen et al. teach integrated biosensor for the detection of SARS-CoV-2 in a wearable material such as a mask or garment [see Abstract; Figure 3; p. 1373, column 2].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Matsumura et al., Chung et al., Russell et al., Kim et al. and Nguyen et al. to incorporate the diagnostic system of Matsumura et al., Chung et al., and Russell et al. into a wearable face mask, bedding or garment for contact with human or animal skin because Matsumura et al., Chung et al., and Russell et al. teach diagnostic systems based on gold nanoparticles and antibodies for detection of the presence of antigens in human bodily fluids such as urine, blood or sweat. Kim et al. teach that wearable biosensors are garnering substantial interest due to their potential to provide continuous, real-time physiological information via dynamic, noninvasive measurements of biochemical markers in biofluids, such as sweat, tears, saliva and interstitial fluid. Nguyen et al. teach integrated biosensor for the detection of SARS-CoV-2 in a wearable material such as a mask or garment. One of ordinary skill in the art would have had a reasonable expectation of success and reasonable level of predictability to combine the teachings of Matsumura et al., Chung et al., Russell et al., Kim et al. and Nguyen et al. because both Kim et al. and Nguyen et al. acknowledge the incorporation of diagnostic systems into wearable materials for continuous, real-time physiological information. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Remarks Regarding Prior Art Rejections
19. Applicants’ remarks filed on 04/30/2026 have been fully considered by the examiner; however, they are rendered moot in view of the new rejections set forth above, which were necessitated by applicants’ amendment to the claims.
Conclusion
20. Status of the claims:
Claims 1-5, 8-9, 12-25, 27-33, and 36-40 are pending.
Claims 19-25, 27-33, and 36-40 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-5, 8-9, and 12-18 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
Prosecution Insights