Prosecution Insights
Last updated: April 19, 2026
Application No. 17/801,452

TESTING FOR VIRUSES AND CELLULAR BIOMARKERS

Non-Final OA §103
Filed
Aug 22, 2022
Examiner
SALVOZA, M FRANCO G
Art Unit
1672
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hero Scientific Ltd.
OA Round
1 (Non-Final)
69%
Grant Probability
Favorable
1-2
OA Rounds
3y 2m
To Grant
98%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
414 granted / 600 resolved
+9.0% vs TC avg
Strong +29% interview lift
Without
With
+29.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
46 currently pending
Career history
646
Total Applications
across all art units

Statute-Specific Performance

§101
8.4%
-31.6% vs TC avg
§103
31.0%
-9.0% vs TC avg
§102
12.1%
-27.9% vs TC avg
§112
26.8%
-13.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 600 resolved cases

Office Action

§103
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION Election Restrictions 1 . Applicant’s election without traverse of Group I and species (HPV; immunoassay; one or more detergents; sonication) in the reply filed on 11/14/2025 is acknowledged. Claims 44, 48, 68, 70, 76, 111-113 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025. Claims 1-5 , 9 , 24 , 26-28 , 31 , 32 , 34 , 38 , 39 , 45 , 52 , 53 , 65 , 66 , 85 , 87 , 91 , 109 are under consideration. Information Disclosure Statement 2. The information disclosure statement s (IDS) were submitted on 11/17/2022; 11/14/2025 . The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Abstract 3 . The abstract of the disclosure is objected to because: it contains extraneous numbers (22), (32, 1932). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Specification 4 . The disclosure is objected to because of the following informalities: The use of t rademarked ter ms has been noted in this application on pages 48, 49, 59, 68 . The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required. Claim Rejections - 35 USC § 103 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. 5 . Claims 1-5, 9, 24, 26-28, 31, 32, 38, 52, 53, 65, 66, 85, 87, 91, 109 are rejected under 35 U.S.C. 103 as being unpatentable over Dohale et al. (WO 2017112911)( cited in applicant's IDS submitted 11/17/2022) in view of Ek et al. ("A combination of naso - and oropharyngeal swabs improves the diagnostic yield of respiratory viruses in adult emergency department patients," Infectious Diseases, Vol. 51, No. 4: 241-248 (2019 ))( cited in applicant's IDS submitted 11/17/2022). See claims 1-5, 9, 24, 26-28, 31, 32, 38, 52, 53, 65, 66, 85, 87, 91, 109 as submitted 2/21/2023. Dohale et al. teaches: analyzing sample for viruses [000102]; method comprising adding sample to chamber comprising filter [ 000112]( as recited in claim 1) ; washing sample [000112] ; drawing washing fluid through filter , wherein washing fluid passed through the filter is stored in the waste chamber [000111]; lysis fluid is released into the sample chamber [000112] (interpreted to read upon extraction liquid as recited in claim s 1 , 52 ) ; applying heat to filter and sample to produce lysate; performing reaction and monitoring chamber to determine whether the target of interest is present in the biological sample [00013] (interpreted as extracting cellular components and testing the extraction liquid for presence of the virus as recited in claim s 1 , 3 ; as recited in claim 5; as recited in claim 24; as recited in claim 26 ; as recited in claim 65 ); wherein user may test for presence of organisms from sample, wherein targets are trapped on filters [000248](as recited in claim 2); at least one reaction chamber, wherein aliquoting system delivers at least one aliquot of fluid to each of at least one reaction chamber [0014](as recited in claim 4); wherein targets include nucleic acid for amplification [000103](as recited in claim 28); including detergents [000145](as recited in claim 53); lysis via sonication [000109](as recited in claim 66); use of pre-filter with a larger pore size before smaller pore-sized filter; wherein larger filter can filter out larger impurities and the smaller pore size is used to capture the organism of interest, such as multiple target organisms of different sizes [000142](as recited in claims 85, 87, 91). Dohale et al. does not teach oronasopharyngeal sample (as recited in claim 1); non-cultured (as recited in claim 9); viral target (as recited in claim 26); viral antigen (as recited in claim 27); taken from one or more of oronasopharyngeal cavities (as recited in claim 31); upper respiratory tract (as recited in claim 38) . Ek et al. teaches: samples from nasopharynx and oropharynx with viral load (abstract ) ( as recited in claims 1, 9, 26, 27, 31, 38) ; nasal washes (p. 245)(as recited in claim 32); respiratory viruses influenza, hMPV, RSV (p. 245)(as recited in claim 38); sample collection (p. 242)(as recited in claim 109). Ek et al. also teaches Daley et al., which teaches use of swabs for collection of respiratory epithelial cells from patients (p. 248) ( as recited in claim 1) . One of ordinary skill in the art would have been motivated to test sample of Ek et al. using the method of Dohale et al. Dohale et al. teaches analysis of sample for viruses, and Ek et al. teaches such a sample (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for testing sample of Ek et al. using the method of Dohale et al. There would have been a reasonable expectation of success given the underlying materials and methods (testing samples as taught by Dohale et al. and Ek et al. ) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 6. Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Dohale et al. in view of Ek et al. as applied to claim s 1-5, 9, 24, 26-28, 31, 32, 38, 52, 53, 65, 66, 85, 87, 91, 109 above, and further in view of Bennett et al. (“Comparison of gargle samples and throat swab samples for the detection of respiratory pathogens,” Journal of Virological Methods 248: 83-86 (2017))(See PTO-892: Notice of References Cited). See claim 34 as submitted 2/21/2023. See the teachings of Dohale et al. in view of Ek et al. above. Dohale et al. in view of Ek et al. does not teach : gargled fluid. Bennett et al. teaches: gargle samples and throat swab samples for the detection of respiratory pathogens (title). One of ordinary skill in the art would have been motivated to use sample as taught by Bennett et al. with the method as taught by Dohale et al. in view of Ek et al. Dohale et al. in view of Ek et al. teaches testing of samples for the detection of respiratory pathogens including throat swabs, and Bennett et al., which also teaches testing of samples for the detection of respiratory pathogens including throat swabs, teaches gargled sample as another source for testing for respiratory pathogens (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using sample as taught by Bennett et al. with the method as taught by Dohale et al. in view of Ek et al. There would have been a reasonable expectation of success given the underlying materials (samples as taught by Bennett et al. and Dohale et al. in view of Ek et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 7. Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Dohale et al. in view of Ek et al. as applied to claims 1-5, 9, 24, 26-28, 31, 32, 38, 52, 53, 65, 66, 85, 87, 91, 109 above, and further in view of Gillison et al. (“Human Papillomavirus and Diseases of the Upper Airway: Head and Neck Cancer and Respiratory Papillomatosis,” Vaccine 30S: F34-F54 (2012))(See PTO-892: Notice of References Cited). See claim 3 9 as submitted 2/21/2023. See the teachings of Dohale et al. in view of Ek et al. above , including as to respiratory viruses. Dohale et al. in view of Ek et al. does not teach: HPV. Bennett et al. teaches: sampling using swabs for HPV DNA in oral exfoliated cells (Table 5). One of ordinary skill in the art would have been motivated to test for HPV as taught by Gillison et al. with the method as taught by Dohale et al. in view of Ek et al. Dohale et al. in view of Ek et al. teaches testing of samples for the detection of respiratory pathogens including swabs, and Gillison et al. , which also teaches testing of samples for the detection of respiratory pathogens including swabs, teaches such a virus for testing (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using sample as taught by Gillison et al. with the method as taught by Dohale et al. in view of Ek et al. There would have been a reasonable expectation of success given the underlying materials (samples as taught by Gillison et al. and Dohale et al. in view of Ek et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. 8 . Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Dohale et al. in view of Ek et al. as applied to claims 1-5, 9, 24, 26-28, 31, 32, 38, 52, 53, 65, 66, 85, 87, 91, 109 above , and further in view of Greef et al. ( US 20120316077 )( See PTO-892: Notice of References Cited). See claim 45 as submitted 2/21/2023. See the teachings of Dohale et al. in view of Ek et al. above. It noted that Dohale et al. teaches wherein the invention may employ convention al techniques of biochemistry, immunology within the skill of the art [00097]. Dohale et al. in view of Ek et al. does not teach: immunoassay. Greef et al. teaches: detecting molecule in sample (title); use of immunoassay [0093] . One of ordinary skill in the art would have been motivated to use assay as taught by Greef et al. with the method as taught by Dohale et al. in view of Ek et al. Dohale et al. in view of Ek et al. teaches testing of samples and use of immunology techniques , and Greef et al., which also teaches testing of sample s and use of immunology techniques , teaches such an assay known and used in such methods (See MPEP 2144.06: Substituting equivalents known for the same purpose). One of ordinary skill in the art would have had a reasonable expectation of success for using assay as taught by Greef et al. with the method as taught by Dohale et al. in view of Ek et al. There would have been a reasonable expectation of success given the underlying materials (assays as taught by Greef et al. and Dohale et al. in view of Ek et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Conclusion 9 . No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT M FRANCO G SALVOZA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4468 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:00 to 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, FILLIN "SPE Name?" \* MERGEFORMAT Thomas VIsone can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-0684 . 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. /M FRANCO G SALVOZA/ Primary Examiner, Art Unit 1672
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Prosecution Timeline

Aug 22, 2022
Application Filed
Mar 28, 2026
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
69%
Grant Probability
98%
With Interview (+29.2%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 600 resolved cases by this examiner. Grant probability derived from career allow rate.

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