Prosecution Insights
Last updated: April 19, 2026
Application No. 18/558,874

NUCLEOTIDE AND NUCLEOSIDE THERAPEUTIC COMPOSITIONS, COMBINATIONS AND USES RELATED THERETO

Non-Final OA §102§103§112
Filed
Nov 03, 2023
Examiner
GALSTER, SAMUEL LEONARD
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Emory University
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
3y 2m
To Grant
92%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
54 granted / 100 resolved
-6.0% vs TC avg
Strong +38% interview lift
Without
With
+38.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
55 currently pending
Career history
155
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
37.9%
-2.1% vs TC avg
§102
16.8%
-23.2% vs TC avg
§112
25.8%
-14.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 100 resolved cases

Office Action

§102 §103 §112
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. 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. This office action is a response to applicant’s communication submitted November 3, 2023 , wherein claims 8, 11-12, 14, 37-38, 40-41, 45-46, were preliminarily amended, claims 1-5, 15-36, and 47-51 were canceled , and claim 52 was cancelled . This application is a 371 of PCT/US2022/027784 filed 05/05/2022 and claims benefit of US provisional application 63/184,609 filed 05/05/2021 Claims 6-14, 37-46, and 52 are pending in this application . Drawings The drawings are objected to because: In figure 5 the Oxygen negative charges appear to be cutoff ( ). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The disclosure is objected to because of the following informalities: On page 15 of the instant specification, the phrase “EIDD-0203” is used (line 7), however everywhere else the compound is referred to as “EIDD-2023”. Appropriate correction is required. Claim Interpretation Claim 45 recites, “wherein the host is immune suppressed”. The phrase is interpreted to mean “ a subject in whom any part of the immune system is not working normally, or is working sub-normally, in other words in whom any part of the immune response, or an immune activity is reduced or impaired, whether due to disease or clinical intervention or other treatment, or in any way) ” as defined on page 214 of the instant specification (lines 11-15). Claim Objections Claims 39 and 42 are objected to because of the following informalities: FILLIN "Enter appropriate explanation" \* MERGEFORMAT In claims 39 and 42, the term "coxsackie" in the phrase "coxsackie A16" should be capitalized because the phrase is referring to a specific species of coxsackie virus . This would also be consistent with instant claim 44 which capitalized the term in this claim . See Simmonds (Archives of Virology, 2020, cited on PTO-892, pg. 794 col. 2, para. 2, section c). In claim 39 the phrase “circoviruses ,parvoviruses” should read “circoviruses, parvoviruses”. See 112(b) issues below. Appropriate correction is required. Claim Rejections - 35 USC § 112 (b) The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 6-14, 37-46, and 52 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claims 6-7, 9, 11-13, 37-39, and 41-45: Claims 6 and 9 recites inter alia, “ ”. However, the variable M is not defined by the claims. A person of ordinary skill would be unable to determine the metes and bounds of the variable thereby rendering the claim indefinite. Claims 7, 37-39, 41-45, which depend from claim 6 and claims 11-13 which depend from claim 9 are similarly rejected. Regarding claims 7-8, and 10-14 : In claims 7 -8 and 10-14, the claims are attempting to limit the specific compound formulas within the composition, however, as written it is not clear that is the case. For example, claim 7 recites inter alia, “The composition of claim 6, wherein U is O;”. For example claim 12 recites inter alia, “The composition of claim 11 having a structure represented by formula Ii.”. As written it appears the claims are reciting limitations to the structure of the composition and not the compound. The claims should be amended in such a way as to clarify that the recited variables are limiting the compound formula within the composition. The lack of clarity in the scope renders claims 7-8 and 10-14 indefinite. Regarding claim 39: The phrase "which include" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Regarding claims 40: Claim 40 recites inter alia, “is administered with one of the following compounds:”. It is unclear whether the recited one or more following compounds are meant to be a specific compound represented by the formula of instant claim 6, or is meant to recite an additional specific compound to be administered. For Examination purposes the claim will be interpreted that the compounds following the phrase are specific compounds represented by the formula of instant claim 6. Regarding claim 46: Claim 46 recites “ “. It is unclear whether the recited compound is meant to be a specific compound represented by the formula of instant claim 6, or is meant to recite an additional specific compound to be administered alongside a compound represented by the formula of instant claim 6. Additionally it is unclear whether vapendavir is meant to be the second antiviral agent, or is administered alongside a second antiviral agent. For Examination purposes the claim will be interpreted that the compound is meant to be a specific compound represented by the formula of instant claim 6 and vapendavir is the second antiviral agent. Regarding claim 52: Claim 52 recites “ “. It is unclear whether the recited compound is meant to be a specific compound represented by the formula of instant claim 6, or is meant to recite an additional specific compound to be administered alongside a compound represented by the formula of instant claim 6. Additionally it is unclear whether vapendavir is meant to be the second antiviral agent, or is administered alongside a second antiviral agent. For Examination purposes the claim will be interpreted that the compound is meant to be a specific compound represented by the formula of instant claim 6 and vapendavir is the second antiviral agent. 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. Claims 6-14, 37 -39, and 45 are rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being anticipated by Liotta (WO 2016145142, IDS filed May 27, 2025) . Regarding claims 6-14, 37- 39 , and 45 : Liotta teaches nucleotide and nucleoside therapeutic compositions and uses in treating infectious diseases, viral infections, and cancer, where the base of the nucleotide or nucleoside contains at least one thiol, thione or thioether (abstract). Liotta teaches the method can be used to treat viral infections from RNA virus, DNA virus, or retrovirus (pg. 5, lines 1-10). Liotta teaches compounds of the invention can be administered in combination with a second antiviral agent such as pleconaril (pg. 194, lines 8-16). Liotta teaches compositions of one of the following compounds: is administered together with a second antiviral agent described above (pg. 194, lines 20-23) . Compound 2023 meets the structural limitations as recited by instant claims 6-14. Liotta teaches in certain embodiments a method of treating a subject diagnosed with hepatitis B virus (HBV), wherein the subject is immunocompromised (i.e. immune suppressed, pg. 193, lines 21-28, 29-31). Liotta teaches l iposomal suspensions (including liposomes targeted to viral antigens) may also be prepared by conventional methods to produce pharmaceutically acceptable carriers , t his may be appropriate for the delivery of free nucleosides, acyl nucleosides or phosphate ester prodrug forms of the nucleoside compounds according to the present invention (pg. 213, lines 4-7) . 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 40 is rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO 2016145142, IDS filed May 27, 2025) as applied to claims 6-14, 37-39, and 45 above . Regarding claim 40: As discussed above, Liotta teaches the method of claim 38. Liotta does not specifically teach a combination of the claimed compound with a second antiviral agent such as pleconaril. However, Liotta teaches compounds of the invention can be administered in combination with a second antiviral agent such as pleconaril (pg. 194, lines 8-16). Liotta teaches compositions of one of the following compounds: is administered together with a second antiviral agent described above (pg. 194, lines 20-23). Thus, a person of ordinary skill would recognize the claimed composition as being encompassed by Liotta given the close proximity between the specific compounds and the specific recitation of pleconaril in the list of viable second anti-viral agents. Claim s 41-4 4 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO 2016145142, IDS filed May 27, 2025) as applied to claims 6-14, 37-40, and 45 above in view of Liotta (ACS Med. Chem. Lett., 2018, cited on PTO-892, hereinafter referred to as Liotta (ACS Med. Chem. Lett.)) . Regarding claims 41-4 4 : As discussed above, Liotta teaches the method of claim 38. Liotta suggests generally that the method is applicable to enterovirus and rhinovirus (pg. 184, lines 3-15). Liotta includes the enteroviruses human coxsackieviruses A1-A22 and A24 ( i.e. coxsackievirus A16 falls within this grouping, pg. 5, lines 11-16, pg. 184, lines 3-15). Liotta does not specifically demonstrate a method of treating enterovirus and rhinovirus. However, Liotta (ACS Med. Chem. Lett.) teaches that EID-2023 is an orally available treatment for rhino- and enteroviruses with extensive and positive safety data (pg. 406, col. 2, para. 2, last bullet point). Taken together, it would have been prima facie obvious to apply the method to enterovirus , such as c ox sackies virus and rhinovirus specifically as suggested by Liotta and supported by Liotta (ACS Med. Chem. Lett.) . A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compound 2023 is an established antiviral in the art of treating these viruses specifically. Claim s 46 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO 2016145142, IDS filed May 27, 2025) and Liotta (ACS Med. Chem. Lett., 2018, cited on PTO-892, hereinafter referred to as Liotta (ACS Med. Chem. Lett.)) as applied to claims 6-14 and 37-45 above in view of Neyts (WO 2011/160191, IDS filed May 27, 2025) as evidenced by Lanko (Antiviral Research, 2021, cited on PTO-892). Regarding claims 46 and 52: As discussed above the prior art render obvious everything as discussed above, except wherein vapendavir is included in the composition as recited by instant claims 46 and 52. However, Neyts teaches the treatment of enteroviruses with the following compound: (abstract). Neyts teaches the compound can be used in combination with a second anti-enteroviral agent for the treatment of an enteroviral infection (pg. 7, lines 1-5). According to Lanko, this compound is known as vapendavir (pg. 5, figure 3). Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to modify the composition such that it includes vapendavir as the second anti-viral agent. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as both the claimed compound and vapendavir are known antiviral agent s effective against enteroviruses, and the art teaches generally the use of combination therapies against viral infections. Conclusion No claims are allowed in this action. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Painter (WO 2019173602, cited on PTO-892) teaches halogen containing nucleotide and nucleoside compositions useful for the treatment of viral infections (abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SAMUEL L GALSTER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0933 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:00 AM - 5:00 PM . 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. /S.L.G./ Examiner, Art Unit 1693 /ANDREA OLSON/ Primary Examiner, Art Unit 1693
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Prosecution Timeline

Nov 03, 2023
Application Filed
Feb 27, 2026
Non-Final Rejection — §102, §103, §112 (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
54%
Grant Probability
92%
With Interview (+38.2%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 100 resolved cases by this examiner. Grant probability derived from career allow rate.

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