Prosecution Insights
Last updated: April 19, 2026
Application No. 18/540,608

ADVANTAGEOUS ANTI-HCV COMBINATION THERAPY

Non-Final OA §DP
Filed
Dec 14, 2023
Examiner
LEWIS, PATRICK T
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Atea Pharmaceuticals, Inc.
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
2y 6m
To Grant
89%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
844 granted / 1135 resolved
+14.4% vs TC avg
Moderate +14% lift
Without
With
+14.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
40 currently pending
Career history
1175
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
30.5%
-9.5% vs TC avg
§102
20.4%
-19.6% vs TC avg
§112
21.4%
-18.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1135 resolved cases

Office Action

§DP
DETAILED ACTION 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. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim s 1-20 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-20 of U.S. Patent No. 12,458,656 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference(s) between the claims is that the claims of the instant application read upon a method wherein Compound(s) 1 and/or 2 are optionally in a pharmaceutically acceptable carrier. The method(s) of the reference patent does not preclude a method wherein Compound(s) 1 and/or 2 are optionally in a pharmaceutically acceptable carrier. Thus, claims 1-20 are anticipated. Claims 21-26 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-20 of U.S. Patent No. 12,458,656 B2 in view of Lawitz , Eric, et al. "Efficacy and safety of a two ‐ drug direct ‐ acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6." Journal of Viral Hepatitis 26.9 (2019): 1127-1138. Claims 21-26 of the instant application differs from claims 1-20 of the reference patent in that the reference patent does not explicitly recite a method wherein the HCV infection is genotype 1, 2, 3, 4, 5, or 6; however, this deficiency would have been obvious in view of the teachings of Lawitz as Lawitz teaches a method of treating adults with chronic HCV genotype 1, 2, 3, 4, 5, or 6 comprising the administration of ruzasvir . One would have been motivated with a reasonable expectation of success as Lawitz teaches that the combination of ruzasvir and uprifosbuvir for 12 weeks was generally well tolerated (page 1136). High efficacy was observed in participants with HCV GT1, GT2, GT4, GT5, and GT6 infection, with lower efficacy in those with GT3 infection. Thus, claims 21-26 would have been obvious based upon the preponderance of evidence. Conclusion Claims 1-27 are pending. Claims 1-26 are rejected. Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No claims are allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Berliba et al. Antimicrobial Agents and Chemotherapy (2019), Vol. 63, Issue 12, e01201-19 ( Berliba ) teaches that AT-527 (e.g., instant Compound 1-A) is a novel modified guanosine nucleotide prodrug inhibitor of the hepatitis C virus (HCV) NS5B polymerase (Abstract). Yu et al. US 9,555,038 B2 (Yu) relates to heterocycle-substituted tetracyclic compounds, compositions comprising at least one heterocycle-substituted. tetracyclic compound, and methods of using the heterocycle-substituted tetracyclic compounds for treating or preventing HCV infection in a patient (column 1, lines 18-23). Yu further teaches a method of treating HCV in a human patient comprising the administration of ruzasvir (e.g., MK-8408, instant Compound 2). See claim 10. The specification discloses synergistic effects of compounds 1 and 2 in combination for treating HCV. See page 10. Contacts Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PATRICK T LEWIS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0655 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday to Friday, 10 AM to 4 PM EST (Maxi Flex) . 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 Renee Claytor can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8394 . 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. /PATRICK T LEWIS/ Primary Examiner, Art Unit 1691 /PL/
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Prosecution Timeline

Dec 14, 2023
Application Filed
Mar 17, 2026
Non-Final Rejection — §DP (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
74%
Grant Probability
89%
With Interview (+14.3%)
2y 6m
Median Time to Grant
Low
PTA Risk
Based on 1135 resolved cases by this examiner. Grant probability derived from career allow rate.

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