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
2. This Office Action is responsive to Applicant’s Remarks, filed January 21, 2026. The remarks, filed January 21, 2026, is entered, wherein no claim is amended, claims 5 – 8, 26 – 27, and 30 are withdrawn, and claims 12 – 20 and 28 are canceled.
Claims 1 – 4, 9 – 11, 21 – 25, and 29 are currently examined.
Priority
3. This application is a national stage application of PCT/IB2020/055235, filed June 3, 2020, which claims benefit of domestic application 62/860,543, filed June 12, 2019.
The following are maintained grounds of rejection necessitated by Applicant’s Remarks, filed January 21, 2026, wherein no claim is amended, claims 5 – 8, 26 – 27, and 30 are withdrawn, and claims 12 – 20 and 28 are canceled. Previously cited references have been used to establish the maintained grounds of rejection.
Maintained Claim Rejections - 35 USC § 103
4. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 4, 9 – 11, 21 – 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gerster et al. (Journal of Medicinal Chemistry, 2005, Vol. 48, Issue 10, page 3481 – 3491, cited in the previous Office Action mailed October 22, 2025).
a. Regarding claims 1 – 4, 9 – 11, 21 – 23, and 25, Gerster et al. teach 1H-Imidazo-[4,5-c]quinolines compounds are able to inhibit virus lesion development in an intravaginal guinea pig herpes simplex virus-2 assay. This antiviral activity can be attributed to the ability of these molecules to induce the production of cytokines, especially interferon (IFN) (Abstract). Gerster et al. further disclose that IFN is a potential treatment for viral infection (page 3481, Left Col., para. 1). Compound 38 has the chemical structure:
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wherein R1 is CH2CH2Ph. Compound 24 teaches R1 to be CH(CH3)2 (page 3482, Figure 2). A single branching substituent at the α position of the carbon backbone, like compound 24, will also induce cytokines (page 3484, Right Col., para. 3). Gerster et al. disclose that the introduction of a phenyl group at the terminus of an alkyl chain shown in compound 38 gives active IFN inducer (page 3484, Right Col., para. 3).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify compound 24 based on compound 38 as taught by Gerster et al. to arrive at the claim compound with the R1 that is an alkyl, such as C1-6alkyl because Gerster et al. suggest and demonstrate the addition of phenyl group to the terminus of an alkyl group will yield IFN induction effect. One would have been motivated to modify compound 24 based on compound 38 as taught by Gerster et al. for the same purpose because Gerster et al. teach that the introduction of a phenyl group at the terminus of an alkyl chain gives active IFN inducer, which is an advantage. Although Gerster et al. do not teach a pharmaceutical composition comprising the claimed compound and a pharmaceutical acceptable carrier, it is known in the art that pharmaceutical acceptable carrier is used in formulating a drug. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to modify compound 24 based on compound 38 as taught by Gerster et al. to arrive at the claim compound with the R1 that is an alkyl, such as -C1-6alkyl because Gerster et al. teach the compound 24 and provide the beneficial effect of introducing a phenyl group to the terminus of an alkyl chain.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed January 21, 2026, have been fully considered and are found to be not persuasive.
Regarding Gerster et al., Applicant argues that the added “bulk” near the imidazole nitrogen can cause a reduction in activity because compound 27 having R1 = -C(CH3)3 and compound 31 having R1 = -Ph show no activity. Therefore, in no way could a skilled artisan expect, with any reasonable amount of certainty, whether or not R1 = -CH(CH3)CH2Ph would be too bulky and shut down activity. However, the argument is not persuasive. Gerster et al. do not teach that increased substitution or “bulk” at R1 reduces activity. To the contrary, Gerster et al. explicitly evaluate the effect of R1 substitution on IFN induction and disclose numerous active compounds being different alkyl substituents at R1, including methyl, ethyl, propyl, isopropyl, butyl, and related alkyl groups, which retain IFN-inducing activity. Thus, Gerster et al. teach that R1 is a variable and provide specific guidance that a range of alkyl substituents is biologically active. The inactivity of some substituents does not negate the reasonable expectation of success for selecting from the working examples. Obviousness does not require absolute predictability, but only a reasonable expectation of success. As Gerster et al. provide a list of active R1 examples, one of ordinary skill in the art would have found it obvious to select and modify the R1 substituents with a reasonable expectation of retaining activity.
Maintained Double Patenting
5. 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 – 4, 9 – 11, 21 – 25, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, 6 – 8, 12 – 15 of U.S. Patent No. 11370788B2 in view of Gerster et al. (Journal of Medicinal Chemistry, 2005, Vol. 48, Issue 10, page 3481 – 3491, cited in the previous Office Action mailed October 22, 2025).
a. Regarding claims 1 – 4, 9 – 11, 21 – 25, and 29, ‘788B2 teaches a compound of Formula (I):
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wherein n is 0; R1 is -CH2OCH2CH3; and R2 is hydrogen (claims 1 and 6 – 8). ‘788B2 also teaches the enantiomers of Formula (I):
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and
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(claims 2 – 3).
The compound of Formula (I) is used as a vaccine adjuvant (claim 12). ‘788B2 further teaches a pharmaceutical composition comprising a therapeutically effective amount of a compound of Formula (I) in combination with a pharmaceutically acceptable carrier, wherein the compound of Formula (I) will induce biosynthesis of IFN in a human or animal (claims 13 – 15).
However, ‘788B2 teaches
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instead of CH2Ph.
Gerster et al. teach 1H-Imidazo-[4,5-c]quinolines compounds are able to inhibit virus lesion development in an intravaginal guinea pig herpes simplex virus-2 assay. This antiviral activity can be attributed to the ability of these molecules to induce the production of cytokines, especially interferon (IFN) (Abstract). Gerster et al. further disclose that IFN is a potential treatment for viral infection (page 3481, Left Col., para. 1). Compound 38 has the chemical structure:
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wherein R1 is CH2CH2Ph (page 3482, Figure 2). Gerster et al. disclose that the introduction of a phenyl group at the terminus of an alkyl chain shown in compound 38 gives active IFN inducer (page 3484, Right Col., para. 3).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the
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moiety of Formula (I) as taught by ‘788B2 with the CH2Ph in compound 38 in view of Gerster et al. because both reference teach imidazo[4,5-c]quinoline compounds that are used for inducing IFN cytokines. One skilled in the art would have been motivated to substitute
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moiety with CH2Ph because Gerster et al. teach that compound 38 with the phenyl terminal will induce cytokines and ‘788B2 teaches the same core compound with the R1 substituent that also induce cytokines. It would have been obvious to combine because these substituents or moieties in the same core structure are known separately in the prior art for the purpose of inducing cytokine. One of ordinary skill in the art would have had a reasonable expectation of success to substitute the
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moiety of Formula (I) as taught by ‘788B2 with the CH2Ph in compound 38 in view of Gerster et al. because these substituents or moieties in the same core structure when substitute or combined will yield predictable results.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed January 21, 2026, have been fully considered and are found to be not persuasive.
Regarding Gerster et al., the arguments are addressed above.
Conclusion
No claim is found to be allowable.
Applicant's Remarks necessitated the maintained ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOI YAN LEE whose telephone number is 571-270-0265. The examiner can normally be reached Monday - Thursday 7:30 - 17:30.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693