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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 22) drawn to a compound of formula (I),
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wherein L1-2, A, R, and R1 are defined and the species election of 2-(3,5-dichloro-4-((1-cyclopropyl-2-(1,1-difluoroethyl)-1H-benzo[d]imidazol-6-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile with the structure
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in the reply filed on March 3rd, 2026 is acknowledged.
Claims 23 – 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method of treating a disorder ameliorated by activation of thyroid hormone receptor beta), there being no allowable generic or linking claim. Additionally, claims 3 – 4, 6 – 9, 11 – 12, 15 – 17, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected chemical species. Election was made without traverse in the reply filed on March 3rd, 2026.
Hence claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 are being examined on the merits herein.
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.
Claim 21 is 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 21, recites “wherein the compound is selected from the compounds in Table 1,” in lines 2 – 3, without stating the chemical name or chemical structure. Applicant is reminded that, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). (See MPEP 2173.05(s)).
Claim Rejections - 35 USC § 102
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.
(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 – 2, 5, 10, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by International Publication Number WO 2020/169069 A1 to Zhang et. al. (herein after Zhang’069; cited in the IDS dated August 28th, 2025).
Regarding claims 1 – 2, 5, 10, and 22, Zhang’069 teach compounds of Formula (I) or a tautomer or a pharmaceutically acceptable salt thereof, of the structure
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(page 5 paragraph 024). More specifically, Zhang’069 teach species compound I13 of structure
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(claim 1) (page 8 paragraph 050) wherein instant L1 -2 are bonds (claims 5 and 10); instant R and R1 are H; and instant A is
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wherein instant RA is -CN (claim 2). Additionally, Zhang’069 teach that the disclosed compounds, which include compound I13 are useful in the treatment of diseases which are modulated by thyroid hormone analog (page 12 paragraph 066) and can be used in pharmaceutical compositions with a pharmaceutically acceptable carrier and/or adjuvant (page 13 paragraph 067).
Claim Rejections - 35 USC § 103
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2020/169069 A1 to Zhang et. al. (herein after Zhang’069; cited in the IDS dated August 28th, 2025).
Regarding claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22, Zhang’069 teach compounds of Formula (I) or a tautomer or a pharmaceutically acceptable salt thereof, of the structure
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(page 5 paragraph 024). More specifically, Zhang’069 teach compounds of Formula (V), or a tautomer or pharmaceutically acceptable salt thereof
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(claim 1) (page 11 paragraph 060) wherein instant L1 -2 are bonds (claims 5 and 10); and instant A is
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wherein instant RA is -CN (claim 2); wherein reference A is O; reference R3 and R2 are Cl (page 11 paragraph 060); wherein B is
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, R4 is cyclopropyl (claims 18 – 19)(page 11 paragraph 063); wherein R5 is C2 alkyl (page 11 paragraph 0062) which includes substituted (claims 13 – 14) (page 17 paragraph 091). More specifically, Zhang’069 teach species compound I13 of structure
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(claim 1) (page 8 paragraph 050) wherein instant L1 -2 are bonds (claims 5 and 10); instant R and R1 are H; and instant A is
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wherein instant RA is -CN (claim 2). Additionally, Zhang’069 teach that the disclosed compounds, which include compound I13 are useful in the treatment of diseases which are modulated by thyroid hormone analog (page 12 paragraph 066) and can be used in pharmaceutical compositions with a pharmaceutically acceptable carrier and/or adjuvant (page 13 paragraph 067). Moreover, Zhang’069 teach that the compounds of the disclosure have been found to be thyroid hormone analogs (page 12 paragraph 066) and can therefore, be used in the treatment and/or prophylaxis of diseases which are modulated by thyroid hormone analogs (page 12 paragraph 066).
Now while Zhang’069 does not teach a compound wherein prior art B is
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; as described above Zhang’069 does teach the structural features of the elected species, that is R4 is cyclopropyl (claims 18 – 19)(page 11 paragraph 063); wherein R5 is C2 alkyl (page 11 paragraph 0062) which includes substituted (claims 13 – 14) (page 17 paragraph 091); using the scaffold of compound I13. Moreover, given that the skill level of one of ordinary skill in the pharmaceutical arts is relatively high such artisan would have been able to use the teachings of Zhang’069 to synthesize the elected species. Therefore, it would have been obvious to one of ordinary skill in the art to modify the teachings of Zhang’069 to make the elected species because each of the structural features were structural options taught.
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, 5, 10, 13 – 14, 18 – 19, and 21 – 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 5, 8 – 10, 12, 14, 16, 18, 21 – 24, 28 – 29, and 31 of U.S. Patent No. US 12528791 B2 to Kirschberg et. al. (herein after Kirschberg’791; cited in the IDS dated March 3rd, 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the conflicting copending application and the invention direct to a compound of formula (I),
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(reference claims 1 and 30; instant claims 1 and 21) wherein
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is
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(reference claims 5, and 8 – 10; instant claim 1); wherein A is
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(reference claim 2; instant claims 1 – 2); wherein Z1-3 are CH (reference claims 12, 14, 16, and 18; instant claim 1); wherein R1 is cyclopropyl (reference claims 21 – 22, and 24; instant claims 5, 10, and 18 – 19); and wherein R2 is ethyl disubstituted with F (reference claim 23 and 28 – 29; instant claims 13 – 14). Moreover both copending applications direct to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient (reference claim 31; instant claim 22).
Claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 5, 7 – 10, 12, 14, 16, 18, 21 – 22, and 30 of copending Application No. 19/426869 to Kirschberg et. al. (reference application; herein after Kirschberg’869).
Although the claims at issue are not identical, they are not patentably distinct from each other because both conflicting copending applications direct to a compound of formula (I),
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(reference claims 1 and 30; instant claims 1 and 21) wherein
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is
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(reference claims 5 - 10; instant claim 1); wherein A is
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(reference claim 2; instant claims 1 – 2); wherein Z1-3 are CH (reference claims 12, 14, 16, and 18; instant claim 1); wherein R1 is cyclopropyl (reference claims 21 – 22; instant claims 5, 10, and 18 – 19); and wherein R2 is ethyl disubstituted with F (reference claim 23; instant claims 13 – 14). Moreover both copending applications direct to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient (reference claim 31; instant claim 22).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627