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
Status of 18/270,028
Claims 1-15 are currently pending.
Priority
Instant application 18/270,028, filed 6/28/2023, claims priority as follows:
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The foreign priority document submitted in the file wrapper is not translated to English, and as a result, priority cannot be established. Thus, the instant claims are granted the effective filing date of 12/28/2021.
Information Disclosure Statement
All references from the IDS’s submitted on 6/28/2023, 8/20/2024, and 1/22/2025 have been considered unless marked with a strikethrough.
Election/Restriction
Applicant’s election of Group I, claims 1-12 and 15, drawn to compounds and compositions of formula I, without traverse in the reply filed 1/5/2026 is acknowledged. Applicant’s election of Example 46:
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In the same reply, is also acknowledged. The Examiner notes that though the image depicts incorrect valency in the 3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine moiety, the nitrogen should have a hydrogen atom to complete valency as described in the chemical name of Example 46.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 102 rejection below. In the interest of compact prosecution, the Examiner expanded her search to compounds of formula I when R1 is alkyl, R2 is H, R3 is H, X is O, L is O, n is 2, both R4’s are halogen, R5 is cyano, and R6 is H. Stated differently, the search was expanded from the elected species to additional substituents of R1 and R2. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-2, 4, 8-12, and 15 read on the elected and expanded species. Claims 3, 5-7, and 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, 9-10, 12, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aligos Therapeutics, Inc. (WO 2022/099044 A1, cited in the IDS of 1/22/2025, herein after “Aligos”). Aligos qualifies as prior art under 35 U.S.C. 102(a)(2) because the filing date is before that of the effective filing date of the instant application. This rejection applies to the elected species.
The reference Aligos discloses 2-pyridones as thyroid hormone receptor modulators (abstract), and specifically discloses Example 35 (page 170, paras [00436]-[00437]):
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Which anticipates the elected species of instant formula I:
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When R1 and R2 together with the atoms to which they are attached form a 4-membered heterocycloalkyl, where the heterocycloalkyl is substituted with one C1 alkyl, R3 is hydrogen, X is O, L is O, n is 2, both R4’s are halogen, R5 is cyano, and R6 is hydrogen. Further, Aligos teaches Example 35 in DMSO-d6 for NMR characterization, which constitutes a pharmaceutical preparation. Thus, Aligos anticipates instant claims 1, 4, 6-7, 9-10, 12, and 15.
Claims 1, 2, 4, 8-12, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sunshine Lake Pharma Co., Ltd. (US 2022/0411400, cited in the IDS of 6/28/2023, herein after “Sunshine”). Sunshine qualifies as prior art under 35 U.S.C. 102(a)(2) because the filing date is before that of the effective filing date of the instant application. This rejection applies to the expanded species.
The reference Sunshine chemical compounds as a thyroid hormone beta receptor agonists (abstract), and specifically discloses Example 4 (page 35):
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Which anticipates a compound of instant formula I:
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When R1 is C3 alkyl, R2 is hydrogen, R3 is hydrogen, X is O, L is O, n is 2, both R4’s are halogen, R5 is cyano, and R6 is hydrogen. Further, Sunshine teaches Example 4 in DMSO-d6 for NMR characterization, which constitutes a pharmaceutical preparation (page 36). Thus, Sunshine anticipates instant claims 1, 2, 4, 8-12, and 15.
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, 4, 6-7, 9-10, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/229,638 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the ‘638 Application recites the compound of formula (I):
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Which is the elected species of instant formula I:
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When R1 and R2 together with the atoms to which they are attached form a 4-membered heterocycloalkyl, where the heterocycloalkyl is substituted with one C1 alkyl, R3 is hydrogen, X is O, L is O, n is 2, both R4’s are halogen, R5 is cyano, and R6 is hydrogen.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 4, 8-12, and 15 are rejected. Claims 3, 5-7, and 13-14 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621