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 .
Priority
The instant application, filed 03/09/2022, is a national stage entry of PCT/US2020/050173, filed 09/10/2020, which claims domestic priority to provisional application to 62/898,066, filed 09/10/2019.
Amendments and Claim Status
The following amendment filed on 12/10/2025 is acknowledged and entered.
Claims 1, 5, 7, 20, 24, and 25 are amended;
Claims 13-15 and 23 are cancelled;
Claims 30-32 are added;
Claims 3, 5, 9, 10, 13, 17, 19, 23, 25, and 28 remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species;
Claims 1, 2, 4, 6-8, 11, 12, 16, 18, 20-22, 24, 26, 27, and 29-32 are being examined as they read on the elected species
Claims 1-12, 16-22, and 24-32 are pending.
Information Disclosure Statement
The Information Disclosure Statement filed on 12/10/2025 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Response to arguments
Applicant’s arguments filed 12/10/2025 with respect to the claim objections and claim rejections under 35 U.S.C. §§ 112(b) and 103, as well as the double patenting rejections have been fully considered.
With respect to the rejection of claims 24 and 25 under U.S.C. § 112(b), the inclusion of the chemical structures within the claims is sufficient to overcome the rejection. As such, the rejection is hereby withdrawn.
However, the compounds that have been included by Applicant to overcome the rejection are of very low resolution, and an objection to said claims is included hereinafter as a result of the amendment.
With respect to the rejection of claims 1, 2, 4, 6-8, 11, 12, 14, 16, 18, 20-22, 24, 26, 27, and 29 under 35 U.S.C. § 103 as being unpatentable over No et al. (WO 2011/113606 A1, published September 22, 2011, provided on IDS filed 06/09/2022) hereinafter No, in view of Patani et al. (Chem. Rev. 1996, 96, 3147-317, published December 19, 1996), hereinafter Patani, Applicant arguments have been fully considered and are sufficient to overcome the rejection.
Applicant’s argument that No is not sufficiently directed to the elected species is persuasive. In particular, No does not disclose exemplified compounds sufficiently close to the elected species to reasonably direct a person of ordinary skill in the art toward without impermissible hindsight. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1, 2, 4, 6-8, 11, 12, 14, 16, 18, 20-22, 24, 26, 27, and 29 rejected under 35 U.S.C. § 103 as being unpatentable over Kim et al. (WO 2015014993 A2, published February 5, 2015, provided on IDS filed 06/09/2022) hereinafter Kim, in view of Patani (see earlier citation), Applicant arguments have been fully considered and are sufficient to overcome the rejection.
Applicant’s argument that Kim is not sufficiently directed to the elected species is persuasive. In particular, Kim does not disclose exemplified compounds sufficiently close to the elected species to reasonably direct a person of ordinary skill in the art without impermissible hindsight. Accordingly, the rejection is hereby withdrawn.
With respect to the rejection of claims 1, 2, 4-7, 11, 12, 14, 16, 18, 20-22, and 26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 17/614,407, (reference application, US 20220235047 A1), Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below. The arguments made by Applicant are herein addressed as follows.
Applicant argues that because neither the instant application nor the co-pending application have allowed claims, the obviousness -type double patenting rejection should be held in abeyance until allowability is determined in at least one application.
Applicant’s argument is unpersuasive because an obviousness-type double patenting rejection is properly made whenever claims in two commonly owned/authored applications are not patently distinct, regardless of whether or not either claim set has been allowed. USPTO practice does not require allowance of claims in either application as a prerequisite to make or maintain an ODP rejection. In fact, this specific rejection is a provisional nonstatutory double patenting rejection precisely because the co-pending claims have not yet been patented. The purpose of an obviousness-type double patenting rejection is to prevent the unjustified extension of patent term to claims that are patentable he indistinct, and such concerns arise during examination, and not only allowance. Accordingly, the rejection need not be held in abeyance.
Applicants may overcome the rejection by amending either claim set to render them patently distinct from one another, submit arguments demonstrating patentable distinction, or by filing a terminal disclaimer, if appropriate. Absent such action, the rejection is hereby maintained.
With respect to the rejection of claims 1, 2, 4-7, 11, 12, 14, 16, 18, 20-22, and 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, and 13 of U.S. Patent No. 11/820,767, Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below. The arguments made by Applicant are herein addressed as follows.
Applicant argues that the claims of the patented case are directed to methods of use, whereas the instant claims are directed to compounds per se, and therefore the claims are patentably distinct.
Applicant’s argument is found unpersuasive because practicing the method necessarily requires the use of the instantly claimed compounds. Here, the methods of the patent necessarily encompass administration of compounds falling within the scope of the instant claims. As such, the instant claims read on the compounds used in the patent’s method.
Applicant further contends that claim one of the patent broadly defines substituents without limitation, whereas the instant claims are directed to a defined subset of compounds that allegedly exhibit unexpected activity, thereby establishing patentable distinction.
Applicants argument is found unpersuasive because the instant claims merely carve out a subset of compounds that are fully encompassed by the broader scope of the patented claims, which are necessarily usable in the claimed methods. Furthermore, alleged evidence of unexpected results does not overcome an obviousness-type double patenting rejection, as the inquiry focuses solely on preventing unjustified extension of patent term, not comparative patentability.
With respect to new claims 30-32, the teachings of the patented compounds overlap with that of the newly added instant claims. Accordingly, claims 30-32 are further rejected on the grounds of nonstatutory double patenting.
Applicants may overcome the rejection by amending either claim set to render them patently distinct from one another, submit arguments demonstrating patentable distinction, or by filing a terminal disclaimer, if appropriate. Absent such action, the rejection is hereby maintained.
With respect to the rejection of claims 1, 2, 4-7, 11, 12, 14, 16, 18, 20-22, and 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 10919888, Applicant’s arguments have been fully considered but are not persuasive for the reasons set forth below. Furthermore, the amendment to the instant claims striking the value of 0 from the definition of q has changed the scope of the instant claims. As a result of this amendment, the teachings of an additional reference (Patani, see earlier citation) have been incorporated to address the limitations of the instant claims. The arguments made by Applicant are herein addressed as follows.
Applicant argues that the patented claims are directed to compounds wherein q is 0 or ring C is absent, and as such, the double patenting rejection should be withdrawn.
Applicant’s argument is unconvincing because the compounds most certainly have ring C present as demonstrated in Figure 1, below.
In the compounds shown in Figures 1 A and B, ring C is as described in Figure 1D. To clarify both for Applicant and the record, the overlapping claimed compounds are further described according to the substituents as related to definitions of Formula I, as shown in Figure 1C:
Figure 1. Comparison of patented compounds and instantly claimed compounds
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499
979
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Fig 1. a) ND-011544; b) ND-011598; c) instantly claimed Formula (I); instantly claimed Ring C.
Rings
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112
126
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are
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110
245
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R1 is CH3 and m is 1 in both ND-011544 and ND-011598
R2 is CH3 in both ND-011544 and ND-011598
R3a, R3b, and R3c are H in both ND-011544 and ND-011598
R3d is F in both ND-011544 and ND-011598
Ring C is
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164
193
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X is N, Y is N, p is 1 in ND-011544 and 2 in ND-011598
R4 is H, q is 0 in both ND-011544 and ND-011598
R5 is CR5C and R5C is H in both ND-011544 and ND-011598
R6 is CR6C and R6C is H in both ND-011544 and ND-011598
R7 is CR7C and R7C is -CF3 in both ND-011544 and ND-011598
R8 is CR8C and R8C is H in both ND-011544 and ND-011598
R9 is N is ND-011544 and R9 is CR9C and R9C is H in ND-011598
Wherein R4 of the patented compound is H and R4 is alkyl in that of the instant claims, Patani defines this substitution (i.e. methyl for hydrogen) as a classical bioisosteric replacement, based on Grimm’s Hydride displacement law. More specifically, Patani discusses the electronegativity of the methyl group and its physiochemical properties upon replacement for a hydrogen (page 3153). A person of ordinary skill in the art would be directly motivated to replace a hydrogen atom with a methyl group at position R4 of the patented compound, resulting in q=1 in order to electronically modify the patented species in hopes of developing novel therapeutics.
With respect to new claims 30-32, the teachings of the patented compounds overlap with that of the newly added instant claims. Accordingly, claims 30-32 are further rejected on the grounds of nonstatutory double patenting.
As such, Applicant’s argument is unconvincing as the patented compounds fall within the scope of the instant claims, in view of the prior art.
Accordingly, the rejection is hereby maintained.
Applicants may overcome the rejection by amending either claim set to render them patently distinct from one another, submit arguments demonstrating patentable distinction, or by filing a terminal disclaimer, if appropriate. Absent such action, the rejection is hereby maintained.
Regarding all three double patenting rejections, claims 27 and 29 were inadvertently omitted from the listing of claims subject to the nonstatutory double patenting rejection. However, said claims were also included in the previous rejections, since claims 27 and 29 are directed to a pharmaceutical composition and a compound of claim 1, respectively, each reciting the treatment and/or prevention of mycobacterial infection as the intended use, which is necessarily present in the double patenting references. According to MPEP § 2111.02, the recited intended use does not impose any structural or compositional limitation. That is, the subject matter of claims 27 and 29, i.e. the compound of Formula (I), was inherently addressed in the previous rejection. Furthermore, the subject matter of the co-pending application is directed to a medicament comprising the compound of Formula (I) for treating mycobacterial infection (see claim 17 of the co-pending application 17/614,407; patented claim 11 of US 11820767 B3; patented claim 3 of US 10919888 B2). Thus, the cited claims of the co-pending applications read on and encompass the subject matter of claims 27 and 29, which are herein both included in the provisional rejection on the grounds of nonstatutory double patenting.
With respect to new claims 30-32, the teachings of the copending applications overlap with that of the newly added instant claims. Accordingly, claims 30-32 are further provisionally rejected on the grounds of nonstatutory double patenting in all three cases of the double-patenting rejections presented herein.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein.
Claim Objections
Claims 1, 24, and 25 are objected to for the following informalities:
The chemical structures now included as a result of the amendment, filed 12/10/2025, are of very low resolution, which will inadvertently cause issues for the printing office of the USPTO.
Applicant is respectfully asked to submit images of better resolution to convey the two-dimensional structures which Applicant intends to claim.
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, 4-7, 11, 12, 14, 16, 18, 20-22, 26, 27, and 29-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17 of copending Application No. 17/614,407, (reference application, US 20220235047 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both applications are drawn to compounds of overlapping structural nature. Essentially, the claims of the co-pending application read on the chemical compounds as instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 17/614,407, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Claims 1, 2, 4-7, 11, 12, 14, 16, 18, 20-22, 26, 27, and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 11, and 13 of U.S. Patent No. 11820767 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patented case read on chemical compounds encompassed by the claims of the instant application.
Claims 1, 2, 4-7, 11, 12, 14, 16, 18, 20-22, 26, 26, 27, and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10919888 in view of Patani. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patented case read chemical structures encompassed by the claims of the instant application.
Wherein R4 of the patented compound is H and R4 is alkyl in the instant claims, Patani defines this substitution (i.e. hydrogen to methyl) as a classical bioisosteric replacement, based on Grimm’s Hydride displacement law. More specifically, Patani discusses the electronegativity of the methyl group and its physiochemical properties upon replacement for a hydrogen (page 3153). A person of ordinary skill in the art would be directly motivated to replace a hydrogen atom with a methyl group at position R4 of the patented compound in order to electronically modify the existing species in hopes of developing a novel therapeutic compound.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623