Detailed Action
The present office action is in response to the reply filed on 05 Aug 2026.
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 .
Status
Claims 1, 3, 5-7, 9, 11-12, 15-16, 20, 22, 24, 27-30, and 39 of the pending application have been examined on the merits. Claims 34, 36-38, and 40 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 02 Jul 2026. Acknowledgement is made of the cancellation of claims 2, 4, 8, 10, 13-14, 17-19, 21, 23, 25-26, 31-33, and 35.
Priority
Applicants identify the instant application, Serial #: 18/706,666, filed 01 May 2024, as a National Stage Entry of International Application #: PCT/CN2022/129643, filed 03 Nov 2022, which claims priority from Foreign Application #s: PCT/CN2021/138668, filed 16 Dec 2021, and PCT/CN2021/128239, filed 02 Nov 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 01 May 2024, 18 Nov 2025, 10 Jun 2026, and 05 Aug 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Acknowledgement is made of the remarks filed 02 Jul 2026.
Applicant election with traverse of Group I in the reply filed on 02 Jul 2026 is acknowledged. Applicant further elected compound 35 (below) as the species of Formula (I).
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After a search, the elected compound was found free of prior art. Examiner has expanded the Markush search to include the following species of Formula (I):
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A search for this species returned prior art.
The traversal is on the ground(s) that Groups I-III are properly combinable under a single inventive concept and should be examined together.
This is not found persuasive. The Groups lack unity for the reasons outlined in the office action mailed 05 May 2026. Briefly, the groups share the technical feature of the core structure of Formula (I):
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This technical feature is not special in view of the compounds taught by Vedejs et al. (J Org Chem, 1993, 58:1341-1348; provided in IDS 11/18/25). Therefore, the core, being the technical feature shared by the groups, is not a contribution over the art and thus the groups lack unity.
Applicant further argues the concurrent examination of Groups I-III would not constitute a serious search burden according to MPEP § 803.
This is not found persuasive because the instant application is subject to the “Unity of Invention” restriction standard and not the “Independent and Distinct/Undue Search Burden” restriction standard. Examiner respectfully reminds applicant that, as set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art."
The requirement is still deemed proper and is therefore made FINAL.
Claims 34, 36-37, and 40 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02 Jul 2026.
Examiner notes that the relevant anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species which have the same core structure as the instant claims. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-7, 9, 11-12, 15-16, 20, 22, 24, 27-30, and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize the applicant was in possession of the claimed invention as a whole at the time of filing include:
Actual reduction to practice;
Disclosure of drawings or structural chemical formulas;
Sufficient relevant identifying characteristics such as:
Complete structure,
Partial structure,
Physical and/or chemical properties, or
Functional characteristics when coupled with a known or disclosed correlation between function and structure;
Method of making the claimed invention;
Level of skill and knowledge in the art;
Predictability in the art.
While all these factors are considered, a sufficient number for a prima facie case are discussed below.
Regarding claims 1, 3, 5-7, 9, 11-12, 15-16, 20, 22, 24, 27-29, and 39, here, the claims are drawn to "prodrug." Applicant provides no guidance as to prodrugs. The artisan understands that prodrug forms are generally determined a posteriori, and it is only through trial and error that prodrugs are identified. The artisan understands the concept of prodrugs, however the artisan does not per se understand what specifically describes a prodrug form. Han (AAPS Pharmsci, 2000, vol. 2, article 6), cited here for evidence, teaches there is no strict universal definition for a prodrug itself but that, in general, the prodrug is an inactivated form of the drug that activates in vivo to the active form (pg. 1, column 2). While some prodrugs are simply esters or salts, other prodrug forms are not chemically or structurally related to their active form, one example being glucose as the prodrug form of hydrogen peroxide (Table 1, pg. 5), as is hypoxanthine, thus posing a problem as to understanding what is the exact prodrug form of a compound, as hydrogen peroxide has two prodrug forms in the limited set of compounds exemplified in Han.
According to Ettamayer et al. (J Med Chem, 2004, 47:2393-2404), cited here for evidence, prodrugs are often accidental discoveries (pg. 2393, column 2). Furthermore, Testa et al. (Biochem Pharm, 2004, 68:2097-2106), cited here for evidence, teaches:
[A] number of challenges await medicinal chemists and biochemists carrying out prodrug research, such as the additional work involved in synthesis, physiochemical profiling, pharmacokinetic profiling and toxicological assessment. Two of these challenges are introduced here, namely biological variability and toxicity potential. The challenge of biological variety results principally but not only from the huge number and evolutionary diversity of enzymes involved in xenobiotic metabolism. Inter- and intra-species differences in the nature of these enzymes, as well as many other differences such as the nature and level of transporters, may render prodrug optimization difficult to predict and achieve. (pg. 2098, column 2)
Methods of making compounds, in general, are known to the artisan. However, the methods of making any specific prodrug are complex and poorly understood, requiring an undue amount of experimentation to determine if a compound is actually a prodrug, and the instant specification fails to provide guidance to overcome the complexity and difficulties known to the artisan, as discussed above.
Thus, the artisan would have increased difficulty in determining how to convert the claimed compounds into prodrugs.
Regarding claim 30, this claim are similarly rejected as these claims refer back to claim 1, but does not remedy the rationale underpinning the basis for rejecting claim 1.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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)(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.
(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.
Claim(s) 1, 3, 5-7, 9, 11-12, 15-16, 20, 22, 24, 27, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstracts Service (“ethyl 3-(3-fluorophenyl)-5,6,7,8-tetrahydro-8-hydroxyimidazo[1,5-a]pyridine-1-carboxylate,” (CAS 2117960-70-8) CAS Registry File Accessed 11 Sep 2026 from STN, entered into STN 22 Aug 2017), hereinafter CAS.
The instant claims are directed to compounds of Formula (I):
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Examiner has expanded the Markush search to the following compound:
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Which is a species of Formula (I) when X1 and X3 are N; X2 and X4 are C; R1 is C6 aryl substituted with halogen; Rf is absent; Rj is -C(=O)ORc; Rc is C2 alkyl; W is C; R3, R4, and R5 are H; R6 is H; m is 4 and n is 0.
CAS teaches the following compound:
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This compound anticipates the instant claims.
The following anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species which have the same core structure as the instant claims. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1, 5-7, 9, 11-12, 15-16, 20, 30, and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 12,071,411, hereinafter ‘411. ‘411 was published 27 Aug 2024 and has an effective filing date of 19 Oct 2022. Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
‘411 teaches compounds of reference Formula IIb useful as HIF-2α inhibitors (Abstract and column 11, lines 1-10):
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‘411 further teaches compounds of reference Formula IIIb (column 12, lines 5-15):
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The compounds of reference Formulas IIb and IIIb read on the instant claims when p is 1; R1 if H or halogen; R’ is H; R2 is -S(O)2-(C1-C3)alkyl; and R3 is optionally substituted alkyl, heterocycloalkyl, phenyl, or heteroaryl (column 9, lines 1-27). ‘411 provides several specific examples of species which read on the instant Formula (I), including Example 107a (column 243, lines 10-19):
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Further, ‘411 teaches pharmaceutical compositions comprising compounds of the reference disclosure and one or more pharmaceutical excipients (column 55, lines 40-53). Therefore, the reference anticipates the instant claims.
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, 3, 5-7, 9, 11-12, 15-16, 20, 22, 24, 27-30, and 39 are provisionally rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1-8 and 10-25 of copending Application No. 18/009,362 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims are directed to compounds of reference formula (I) which anticipate the compounds of the instant claims (ref claim 1):
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The reference application further claims a pharmaceutical composition comprising a compound of the reference claims and a pharmaceutically acceptable excipient (claim 25).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2016/040809 is considered pertinent for teaching compounds with the same core structure as the instant claims.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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 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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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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