Prosecution Insights
Last updated: April 19, 2026
Application No. 18/568,968

ANTIVIRAL NUCLEOSIDE ANALOGUES

Non-Final OA §102§103§DP
Filed
Dec 11, 2023
Examiner
OLSON, ANDREA STEFFEL
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Albert Einstein College of Medicine
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
50%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
868 granted / 1397 resolved
+2.1% vs TC avg
Minimal -12% lift
Without
With
+-12.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
64 currently pending
Career history
1461
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
37.3%
-2.7% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
21.2%
-18.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1397 resolved cases

Office Action

§102 §103 §DP
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 This application is a national stage application of PCYT/NZ2022/050061, filed May 31, 2022, which claims benefit of provisional application 63/209542, filed June 11, 2021. Claims 1-13 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted December 11, 2023 is acknowledged wherein claims 4-7, 9, 12, and 13 are amended. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1 -13 are rejected under 35 U.S.C. 102 (a)( 2 ) as being anticipated by Shomar Monges et al . (PCT international publication WO2022/038539, Reference included with PTO- 1449 ) Independent claim 1 claims a compound having the formula (I): wherein R 1 can be H, R 2 can be H or -OH, and Y is defined as one of a number of acyl and protected phosphate groups. Shomar Monges et al. discloses compounds having the formula (p. 5 paragraph 10) wherein R 2 can be -OH and R 1 is selected from groups including wherein M 1-5 and Q are all defined in a manner consistent with present claim 1. In particular, M 2 and Q are defines so as to fall within the scope of R 8 and R 9 in present claim 1, M 4 meets the limits of R 6 when it is a C 3 alkyl-O-C 12-18 alkyl, M 3 can be which is isobutyroyl as recited in R 3 in present claim 1, and M 5 can be . Similar embodiments wherein the 2’- position is H are also disclosed. (p. 5 paragraph 11) There structures include embodiments anticipating present claim 1, for example . Regarding claim 2, the structures recited by Shomar Monges all include a H at the position corresponding to R 1 . Regarding claims 4 and 5 the aforementioned structures include embodiments wherein the 2’- position (R 2 ) is OH. Regarding claim s 6 and 8, these claims are anticipated when R 1 is isobutyroyl as discussed above. Regarding claim 7, p. 57 paragraph 126 specifically describes an embodiment wherein M 5 (corresponding to R 5 in present claim 1) is pivaloyl-2-thioethyl. Regarding claim 9, this is anticipated when R 1 is , M 1 is , and M 2 is as recited on p. 57 of Shomar Monges. Regarding present claim 11, certain embodiments such as are additionally anticipated by the disclosure of Shomar Monges for the same reasons given above. Regarding present claim 12, p. 103 paragraph 177 of Shomar Monges discloses pharmaceutical compositions comprising these compounds and a pharmaceutically acceptable carrier. Regarding claim 13, Shomar Monges discloses methods of treating various viral infections including HIV and EBV. (p. 15 paragraph 26) Regarding claims 3 and 10, Shomar Monges discloses the compound . (p. 96 compound XVIB) Looking at this structure, one skilled I the art would have at once envisaged various embodiments of R 1 including ones falling within the scope of the present claims. For these reasons Shomar Monges anticipates the present claims. Claim Rejections - 35 USC § 103 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. Claim s 1, 2, 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Almo et al . (PCT international publication WO2019/040418, Reference included with PTO-892) Independent claim 1 claims a compound having the formula (I): wherein R 1 can be H, R 2 can be H or -OH, and Y is defined as one of a number of acyl and protected phosphate groups. Almo et al. discloses derivatives of 3’,4’-didehydro cytosine triphosphate. (p. 3 paragraph 9) In one embodiment the derivative can have the formula (I) wherein R 2 is cytosine, R 3 can be H, and R 1 can be an acyl or alkoxycarbonyloxy alkyl. (p. 7 paragraph 25) The compounds can also be formula (II) wherein R 1 and R 2 are hydrogen, acyloxyalkyl, acyloxycarbonyl alkyl, or S-acylthioalkyl. (p. 8 paragraph 26) In another embodiment the derivative has the formula (III) wherein R 1 and R 2 can be alkyl or aryl. (p. 8 paragraph 27) Formulae (I)-(III) as disclosed by Almo et al. are gene ri c formulae which encompass the structures of present claim 1. In particular, “acyl or alkoxycarbonyl oxy alkyl” in paragraph 25 encompasses “pivaloyl, isobutyroyl-, or isopropyloxycarbonyloxy-(C 1-3 alkyl)methyl,” in the definition of R 3 in present claim 1 and “C 1-20 alkyl ” in the definition of R 4 paired with carbonyl , acylocyalkyl or S-acylthioalkyl for R 1 and R 2 in paragraph 26 encompass R 5 in present claim 1, and the definitions of R 1 and R 2 in paragraph 27 encompass the definitions of R 7 and R 9 in present claim 1. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the specific embodiments of the structural genera described by Almo which are described in present claim 1. In particular, faced with generically defined chemical groups such as “alkyl,” “acyl,” and “aryl,” one of ordinary skill in the art would have looked to the manner in which the reference defines these groups. In particular, the definition of “alkyl” recited in p. 11 paragraph 36 describes isopropyl and t-butyl as specific embodiments, which would suggest isobutyroyl and pivaloyl when paired with a carbonyl, and the discussion of “phenyl” in p. 11 paragraph 37 would have suggested a C 6 aryl group in positions R 1 and R 2 in paragraph 27 of Almo. Therefore one of ordinary skill in the art would have arrived at the presently claimed structures merely by substituting the specific suggested embodiments of “alkyl” and “aryl” into the generic structures described by Almo. Regarding claims 2, 4, and 5, the values of R 1 and R 2 described in these claims are already disclosed for example in formula II and formula III of Almo cited above. Regarding claims 6-9, these claims describe values of Y which are included in formulae I-III of Almo discussed above. Regarding claim 11, specific structures such as and , for example, would be specific structures made obvious for the reasons discussed above. Regarding present claim 12, p. 15 paragraph 47 of Almo describes a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier. Regarding present claim 13, p. 15 paragraph 51 of Almo describes treating HIV infection. For these reasons Almo et al. renders the present claims prima facie obvious. Claim s 3 and 10 a re rejected under 35 U.S.C. 103 as being unpatentable over Shomar Monges et al . (PCT international publication WO2022/038539, Reference included with PTO- 1449 ) The disclosure of Shomar Monges et al. is discussed above. As discussed previously, it is determined that one skilled in the art would have at once envisaged hydroxylamino cytosine compounds wherein R 1 is -OH based on the disclosure of the structure by Shomar Monges et al. given the disclosure of specific embodiments of R 1 described elsewhere in the reference. However, even assuming for the sake of argument that one skilled in the art would not have envisaged the specific hydroxylamino compounds falling within the scope of present claims 3 and 10 based on this structure, it would still have been obvious to one of ordinary skill in the art at the time of the invention to make hydroxylamino derivatives of the specific compounds described by Shomar Monges et al. One of ordinary skill in the art would have seen the disclosure of a hydroxylamino cytosine as suggesting using this base in any of the specific protected compounds described by the reference. Therefore the invention taken as a whole is prima facie obvious. 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 . Claims 1, 2, 4, 9 , 12, and 13 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1, 7 , 8, 12, and 13 of U.S. Patent No. 11279728 . (Cited in PTO-892, herein referred to as ‘728) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘728 render the present claims obvious . Specifically, claim 1 of ‘728 claims a compound having a formula (I) , (II) , or (III) . The groups R 1 and R 2 in these structures are defined in such a way as to encompass the equivalent positions in the present claims, for example the term “aryl” recited in claim 1 of ‘728 renders obvious the subgenus C 6-12 aryl in groups R 7 and R 9 in present claims 1 and 9. Regarding claims 2 and 4, these definitions of R 1 and R 2 appear in the structures recited in claim 1 of ‘728. Regarding claim 12, claims 7 and 8 of ‘728 describe pharmaceutical compositions comprising these compounds and a pharmaceutically acceptable carrier. Regarding present claim 13, claims 12 and 13 of ‘728 further claim methods of treating viral infections including HIV using these compounds. Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ANDREA OLSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9051 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 6am-3:00pm . 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 Scarlett Y Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5241 . 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. /ANDREA OLSON/ Primary Examiner, Art Unit 1693 3/13/2026
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Prosecution Timeline

Dec 11, 2023
Application Filed
Mar 16, 2026
Non-Final Rejection — §102, §103, §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
62%
Grant Probability
50%
With Interview (-12.1%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 1397 resolved cases by this examiner. Grant probability derived from career allow rate.

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