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 1-2, 4, 6-13, and 15 are currently pending.
Priority
Instant application 18/270,028, filed 6/28/2023, claims priority as follows:
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Submission of the translated, foreign priority document submitted 6/19/2026 is acknowledged, and contains support for the instant claims. Thus, the effective filing date of the instant claims is 12/30/2020.
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.
Response to Arguments/Amendments
The amendment filed 6/19/2026 has been entered. Claims 1, 2, 4, 8, 9, 12, and 13 have been amended. Claims 3, 5, and 14 have been cancelled.
Claims 1, 4, 6-7, 9-10, 12, and 15 were rejected under 35 U.S.C. 102(a)(2) in the Non-Final dated 3/23/2026. In response, Applicant argues that claim 1 is amended to solely recite R1 of formula I can solely be C5-10 aryl or C5-10 heteroaryl; however, the last paragraph of claim 1 recites that R1 and R2 together with the atoms to which they are attached form a 4-10 membered heterocycloalkyl further substituted with a C1 alkyl. The amendments to claim 1 do not overcome the rejection. However, the Examiner agrees with Applicants arguments regarding the priority date of Aligos in combination with the submission of the translated foreign priority documents. Upon the change of the effective filing date of the instant claims to 20 December 2020, and the fact that the Aligos provisional application 63/110,812 dated 06 November 2020 does not contain support for the species previously stated as anticipatory in the Non-Final rejection dated 3/23/2026, the 102(a)(2) rejection with respect to Aligos is overcome. Thus, the rejection is withdrawn.
In an additional rejection under 35 U.S.C. 102(a)(2), claims 1, 2, 4, 8-12, and 15 were rejected in the Non-Final dated 3/23/2026. In response, Applicant amended the instant claims to recite that R1 of formula I can solely be C5-10 aryl or C5-10 heteroaryl, which overcomes the rejection. Thus, the rejection is withdrawn.
Claims 1, 4, 6-7, 9-10, and 12 were provisionally rejected on the ground(s) of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/229,638 in the Non-Final dated 3/23/2026. Applicant has stated a terminal disclaimer has been submitted; however, no terminal disclaimer has been filed with the USPTO. Thus, the rejection is maintained.
Furthermore, Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action.
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.
In the Non-Final dated 3/23/2026, the elected species was searched and prior art was identified. Additionally, an expanded species was also identified in the same Office Action, and both prior art rejections were overcome by amendments to the claims. However, the double patenting rejection was not overcome as a terminal disclaimer was not filed. In the interest of compact prosecution, the scope of the search was expanded to the full scope of formula I. See the 103 rejection below. Claims 1-2, 4, 6-12, and 15 are the subject of this Office Action. Claim 13 remains 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.
MAINTAINED REJECTIONS
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 5-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.
NEW REJECTIONS NECESSITATED BY AMENDMENT
Claim Objections
Claim 4 is objected to for pixelated and illegible images. Appropriate correction is required.
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.
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 1-2, 4, 8-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sunshine Lake Pharma Co., LTD. (US 2022/0411400 A1, 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.
Determining the scope and contents of the prior art
The reference Sunshine teaches chemical compounds as thyroid hormone beta receptor agonists (abstract), and specifically teaches compounds such as Example 4 (page 14):
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Which partially maps to instant formula I:
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When R6 is H, R5 is cyano, n is 2, R4 is halogen, L is -O-, R3 is H, R2 is hydrogen, and X is O. Example 4 was dissolved in DMSO, indicating a pharmaceutical composition, and is demonstrated to have micromolar potency and selectivity for thyroid hormone receptor β over α in EC50 assays (page 75, Table 1). The sole difference between Example 4 of Sunshine and a compound of the instant claims is substitution of an isopropyl group at the N1-position of the pyridone as the instant claims require this substituent to be a C5-10 aryl or C5-10 heteroaryl.
However, Sunshine teaches additional compounds 21-31 (pages 16-17):
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Which partially map to instant formula I:
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When R6 is H, R5 is cyano, n is 2, R4 is halogen, L is -O-, R3 is H, R1 is C5-10 aryl or C5-10 heteroaryl, and X is O. Examples 21-31 of Sunshine are demonstrated to have micromolar potency and selectivity for thyroid hormone receptor β over thyroid hormone receptor α in
EC50 assays (page 75, Table 1). The difference between Examples 21-31 of Sunshine and compounds of the instant claims is the position adjacent to nitrogen in the pyridone ring. In Examples 21-31 of Sunshine, this position is a nitrogen, whereas in compounds of the instant claims, this position is a carbon substituted with R2 where R2 is a hydrogen or C1-6 alkyl.
With respect to claim 11, Sunshine teaches the C6-10 aryl and 5-8 membered heteroaryl of variable R1 of Formula I may be substituted with 1, 2, or 3 F, Cl, or Br (page 78, claim 1).
Ascertaining the differences between the prior art and the claims at issue
Sunshine fails to teach an anticipatory species with a C5-10 aryl or C5-10 heteroaryl substituted at the N1-position of the pyridone.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of compounds able to bind thyroid hormone receptor β. An artisan possess the technical knowledge necessary to make adjustments to the compounds to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said compounds able to bind thyroid hormone receptor β and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious for one of ordinary skill in the art to substitute the isopropyl substituent of the pyridone in Example 4 of Sunshine with the various C5-10 aryl and C5-10 heteroaryl substituents of Examples 21-31 of Sunshine because the compounds are known to have biological activity in the same receptors and structurally similar compounds are expected to have similar properties. Stated differently, the compounds have very close structural similarities and the same utility. A skilled artisan would have been motivated to make such a substitution to identify additional compounds able to bind thyroid hormone receptor β and would have reasonably predicted success in light of the teachings of Sunshine.
Conclusion
Claims 1-2, 4, 6-12, and 15 are rejected. Claim 4 is also objected to. Claim 13 remains withdrawn.
Applicant's amendment necessitated the new 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 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
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