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.
Election/Restrictions
Applicant’s election of “compound 263”:
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(see page 4 of Specification; corresponds to CAS RN: 2764991-95-7), as a species of “Genus formula I of claim 1”, in the reply filed on 10 November 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ provided a compliant species of genus formula I of claim 1:
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, wherein: R2 is H; “m” and “n” is 0; X1 is -C(Rx)- wherein Rx is -NH2; X1 and Y1 are joined together by a double bond; Y1 is -C(Ry)- wherein Ry is -CN; and R1 is H.
Applicants’ compliant species election of compound 263 is free of the prior art.
Examiner extended the Markush search to the species:
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of genus formula I of claim 1, wherein: R2 is H; “m” and “n” is 0; X1 is -S-; X1 and Y1 are joined together by a single bond; Y1 is -CH2-; and R1 is H.
This Markush search extension has prior art.
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species of genus formula I of claim 1 in this Office Action.
The Markush search extension reads on claims 1-5.
Claims 6-7 and 24-39* are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of genus formula I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2025.
*Please note that the compound:
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of claims 24, 31, and 38 are structurally distinct from the genus of claim 21 (at circled R2 which requires a heteroarylalkyl, not seen in R2 of claim 21) AND structurally distinct from the genus of claims 1 and 8. Markush search extension only covers genus formulae I-III [per Election of Species Requirement] and since claims 24, 31, and 38 each purports to depend on claim 1, the compound of claims 24, 31, and 38 will be searched in a later Office Action. Note that claims 24, 31, and 38 will be rejected under 35 USC 112(d) once they are rejoined since they do not correctly further limit claim 1.
Applicant’s election of “compound 249:
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“ (see page 10 of Specification; corresponds to CAS RN: 2764991-80-0), as a species of “Genus formula II of claim 8”, in the reply filed on 10 November 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ elected species of genus formula II of claim 8:
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, wherein: n is 1; R1 is methyl; R3 and R4 are each oxygen (O); R2 is absent; R5 is methyl; and R6 is -O-CH2-CF3, is free of the prior art.
The Examiner extended the Markush search to:
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of genus formula II of claim 8, wherein: “n” is 0; one of R3 and R4 is O and the other is absent; R2 is absent; R5 is methyl; and R6 -O-CH2-CF3
This Markush search extension has prior art.
Therefore, per Markush search practice, the Markush search will not be extended unnecessarily to additional species of genus formula II of claim 8 in this Office Action.
The Markush search extension reads on claims 8 and 13.
Claims 9-12 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of genus formula II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2025.
Applicant’s election of “compound 258:
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” (see page 12 of Specification; corresponds to CAS RN: 2764991-93-5), as a species of “Genus formula III of claim 21”, in the reply filed on 10 November 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ elected species of genus formula III of claim 21:
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, wherein: R1 is methyl; R2 is fluorine-substituted phenyl; and “n” is 0, is free of the prior art.
The Examiner extended the Markush search to the full scope of instant claim 21 but did not find any prior art.
Therefore, only the Election of Species Requirement for claim 21 is withdrawn. The Election of Species Requirements for claims 1 and 8 are each maintained.
Current Status of 18/025,797
This Office Action is responsive to the amended claims of 10 November 2025.
Claims 1-5, 8, 13, and 21-23 have been examined on the merits. Claims 1-2 8, 13, and 22 are original. Claim 3 is previously presented. Claims 4-5, 21, and 23 are currently amended.
Priority
The effective filing date is 17 September 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2 June 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 applicant regards as his invention.
Claims 8 and 13 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.
Claim 8 recites the limitation "-O-(CH2)m-R7" for variable R6. There is insufficient antecedent basis for this limitation in the claim.
As drafted, the variable “m” of the above embodiment for R6 is not defined by the claim 8. Hence, this renders the metes and bounds of claim 8 undefined (hence rendering claim 8 indefinite under 35 USC 112(b)) since the artisan has no idea what integer range constitutes “m”.
Claim 13 is similarly rejected as indefinite under 35 USC 112(b) since it refers back to claim 8 but does not remedy the rationale underpinning the basis for rejecting claim 8.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
NISSBIN (U.S. 4,829,069, referenced in IDS of 2 June 2023).
The prior art reference NISSBIN teaches the compound “4-(2-benzimidazolylmethylthio)-quinazoline”:
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(see col. 2), which is a species of genus formula I of claim 1, wherein: R2 is H; “m” and “n” is 0; X1 is -S-; X1 and Y1 are joined together by a single bond; Y1 is -CH2-; and R1 is H, and pharmaceutically acceptable salts thereof (col. 3).
Further, the limitation “an aryl hydrocarbon receptor (AHR) agonist“ of the instant rejected claims is interpreted as an inherent property/function. “Where the structure recited in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed inherent.” See MPEP 2112.01(I) and (II). This anticipates instant claims 1-4. Furthermore, the analysis from NISSBIN, above, anticipates compound #: 243 of instant claim 5.
Claims 8 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
HACKAM (WO 2018/218143 A1, which is a reference by one or more joint inventors but names someone else [Liu, Jun O] and is published before the grace period begins; furthermore, the Specification does not identify this reference as inventor-originated under 37 CFR 1.77(b)(6)).
The prior art reference HACKAM teaches the AHR agonist compound:
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(see page 11), which is a species of genus formula II of claim 8, wherein: “n” is 0; one of R3 and R4 is O and the other is absent; R2 is absent; R5 is methyl; and R6 -O-CH2-CF3, and pharmaceutically acceptable salts thereof (page 2). This anticipates instant claims 8 and 13.
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 8 and 13 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-2 and 9 of U.S. Patent No. 11,458,141 B2. The instant amended claims of 10 November 2025 were used to write this rejection.
Although the claims at issue are not identical since the reference method claims are drawn to methods of use of the instant compound claims, they are not patentably distinct from each other because the reference claims 1-2 and 9 (especially claim 9) anticipate the AHR agonist compound of instant claims 8 and 13.
All the limitations of instant claims 8 and 13 are seen in the species of reference claim 9. Reference claim 9 is drawn to:
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, which is a species of genus formula II of instant claim 8, wherein: “n” is 0; one of R3 and R4 is O and the other is absent; R2 is absent; R5 is methyl; and R6 -O-CH2-CF3, and pharmaceutically acceptable salts thereof (see reference claims 1-2).
Please file a Terminal Disclaimer (TD) to render moot this rejection.
Conclusion
Claims 1-5, 8, and 13 are not presently allowable as written.
Claims 21-23 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a genus formula III of claim 21.
The instant application was the only application retrieved during a prior art search for the genus formula III of claim 21.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625