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 .
Current Status
This action is responsive to the amended claims of 08/07/2023. Claims 1, 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64-68, 72, 76, 80, 88, 97, and 196-197 are pending. Claims 65-68, 72, 76, 80, 88, 97, and 197 have been withdrawn.
Claim 1, 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64, and 196 have been examined on the merits.
Note, Examiner Bell inherited this application from the prior Examiner.
Election/Restrictions
Applicant’s election of Group I (claims 1, 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64, and 196) and the compound A146 (below) in the reply filed on 01/06/2026 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)).
Compound A146:
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.
A search for the elected compound A146 did not return any prior art (see SEARCH 6 of the attached search notes). Thus, the Markush search was extended to the full scope of the Formula (I) and Formula (I’) as defined in independent claim 1. No prior art was retrieved. Thus, the election requirement of 07/07/2025 is made moot.
Claims 65-68, 72, 76, 80, 88, 97, and 197 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/06/2026.
Note, to expedite time to allowance: The Group II claims (65-68, 72, 76, 80, 88, 97, and 197) do not depend from and do not require all limitations of a Group I claim. Further, the Group II claims are not drawn to a process of use or process of making the Group I compound. Thus, the Group II claims are not eligible for rejoinder (see MPEP 821.04). Since Applicant elected without traverse and to expedite prosecution, Examiner suggests Applicant cancel all Group II claims from the pending claims.
Priority
The effective filing date is 08/31/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/19/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64, and 196 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 lacks commas after the second to last option in the list of moieties from which RB is chosen: “C0-3alkylene-N(RN)Het or C0-3alkyleneN(RN)C(O)Het”. To improve claim form, please add a commas as such: “C0-3alkylene-N(RN)Het, or C0-3alkyleneN(RN)C(O)Het”. Dependent claims 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64, and 196 are similarly objected to since they do not rectify the underlying issue.
Claim 1 recites:
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as part of the definition of RB. To improve consistency in punctuation, 1) the comma annotated with the dashed arrow (above) should be replaced with a semicolon and 2) the semicolon annotated with the solid arrow (above) should be replaced with a comma. This way the major options from which RB is chosen are separated using semicolons and the choices within the three are consistently separated by commas. Dependent claims 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64, and 196 are similarly objected to since they do not rectify the underlying issue.
Claim 39 recites
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. Please add the words “the” and “is” as follows to improve claim form:
“(i) when m is 1, RX is at the 2-position of the pyridine, or (ii) when m is 2, one RX is at the 2-position and the other RX is optionally at the 6-position of the pyridine, and at least one RX is halo or methyl.
Claim 47 recites “and RZ is meta to ring nitrogen”. Please add the word “the” as follows to improve claim form: “and RZ is meta to the ring nitrogen”.
Claim 51 recites “RX is fluoro at 2-position of pyridine”. Please add the word “the” as follows to improve claim form: “RX is fluoro at the 2-position of the pyridine”.
Claim Rejections - 35 USC § 112(b)
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 17, 21, and 64 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 17 recites the limitation wherein RB is chosen from "C3-6 cycloalkyl" in line 3. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites RB may be C0-3alkylene-Het wherein Het is an “aromatic or non-aromatic 4-7 membered ring having 0-3 heteroatoms”. Examiner understands RB may be Het wherein Het may be C4-7 cycloalkyl. Therefore, RB being chosen from C3 cycloalkyl lacks antecedent basis in the claims. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 21 recites the limitation wherein RB is Het or OHet and Het is "C3-6 cycloalkyl" in line 2. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites Het is an “aromatic or non-aromatic 4-7 membered ring having 0-3 heteroatoms”. Examiner understands Het may be C4-7 cycloalkyl. Therefore, Het being chosen from C3 cycloalkyl lacks antecedent basis in the claims. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 64 is drawn to compound structures recited in Table A within the specification. The claim does not recite the claimed structures directly. MPEP 2173.05(s) requires that claims are complete in themselves. Since the claim relies on incorporation by reference to a table in the specification the claim is not complete in itself. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please incorporate the contents of Table A into the claim.
Claim 64 recites compounds A24, A94-95, A162, A167-169, A184, E24-25, and E59-60. There is insufficient antecedent basis for this limitation in the claim. These compounds comprise moieties outside of the scope Formula (I) or (I’) of parent claim 1, as follows:
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A24 RB is C0alkylene-Het but Het cannot be a C3 cycle;
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&
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A94-95 RB, RC, and RY cannot be D, only H is recited in parent claim 1 and no isotopes are included in the claim language;
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,
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, &
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A162 & A167-169 each lack the pyrrolidine between the thiazole and phenyl;
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A184 RB is C0alkylene-N(RN)C(O)Het but Het cannot be a C3 cycle; and
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&
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E24-25 & E59-60 RX cannot be CN. Since these moieties are not recited in the parent claim 1, the compounds lack antecedent basis. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
Note: due to the number of species recited in Table A (Pg. 7-24 of the specification), Examiner kindly asks Applicant review all structures for support in parent claim 1 when importing the structures into the claim set.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17, 21, and 64 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 17 and 21 recite wherein Het is C3 cycloalkyl. Parent claim 1 recites wherein Het may be a 4-7 membered ring and thus does not include a 3 membered C3 cycloalkyl. Thus, claims 17 and 21 recite a limitation outside of the scope of parent claim 1; i.e., they do not properly further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 64 recites compounds A24, A94-95, A162, A167-169, A184, E24-25, and E59-60 which comprise moieties outside of the scope Formula (I) or (I’) of parent claim 1 (see ¶23 above for discussion thereof). Thus, claim 64 recites limitations outside of the scope of parent claim 1; i.e., claim 64 does not properly further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 11, 17, 43, 45, 49, and 62 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claim 203 of copending Application No. 17/434,029 (reference application – claims of 01/02/2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 11, 17, 43, 45, 49, and 62, independent claim 203 of the reference application recites the following compounds which are species of the instant claims Formula (I) or (I’):
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,
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, and
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. A317 recites wherein m, o, & p are 0, R1 is H, RA is H, X is N, Y is CH, and RB is H. A318 recites wherein m is 1, RX is halo, o & p are 0, R1 is H, RA is H, X & Y are CH, and RB is H. A386 recites wherein m & o are 0, R1 is H, RA is N(RN)2 wherein RN is methyl, p is 1, RY is halo, X & Y are CH, and RB is halo. A391 recites wherein m & o are 0, R1 is H, RA is H, X is CH, Y is CF, p is 1, RY is halo, and RB is H. A392 recites wherein m & o are 0, R1 is H, RA is H, X is CF, Y is CH, p is 1, RY is halo, and RB is H. A393 recites wherein m & o are 0, R1 is H, RA is H, X & Y are CH, p is 1, RY is halo, and RB is halo. These compounds represent species of the instant claims; thus, the instant claims are anticipated.
Claims 1 and 196 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 203 of copending Application No. 17/434,029 (reference application – claims of 01/02/2026). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 196, reference claim 203 teaches species of the instant claim 1 (see above). Further, see MPEP 804: "In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02." Here the reference’s supporting disclosure teaches the use of the compound/species as follows: Pg. 29 ¶52 “The disclosure further provides methods for treating cancer in a subject comprising administering to the subject a therapeutically effective amount of the compound, salt, or pharmaceutical composition described herein” and Pg. 30 ¶58 “The compounds described herein can be used to treat or prevent diseases associated with excessive protein secretion, such as inflammation and cancer, improving the quality of life for afflicted individuals”. Thus, the reference claims teach species of the instant claims and the reference’s supporting disclosure teaches a use that overlaps exactly with that of instant claim 196. Therefore, the instantly claimed method is obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 11, 17, 21, 43, 45, 49, 62, 64, and 196 are rejected.
Claims 10, 26, 39, 47, and 51 are objected to.
A search for the compound or salt of Formula (I) and Formula (I’) did not retrieve any prior art; see SEARCH 6 of the attached search notes. The closest art may be considered MCMINN (WO 2020/176863) and KEZAR (WO 2019/046668) – both provided in the IDS of 04/19/2023.
MCMINN, pub. 09/03/2020 and effectively filed 02/28/2019, teaches compounds such as A318
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(Pg. 88) which is a species of instant Formula (I). However, MCMINN is not by another – the only inventors are the two instant inventors McMinn, Dustin and Rao, Meera. Thus, since MCMINN is published after the instant EFD and is not by another, the reference cannot be applied as 102(a)(1) or 102(a)(2) type art. Therefore, the reference cannot be prior art, only close art.
KEZAR, pub. 03/07/2019, teaches compounds such as
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(Pg. 119) and
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(Pg. 126) which share the thiazole-amide core structure with the instant Formulas (I) and (I’) but differ greatly at the moieties attached to either end of this core structure (i.e., the annotated moieties are missing:
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). Thus, KEZAR does not teach species of the instant claims and cannot suggest/make obvious the instant compounds since the taught compounds differ so greatly from the instant species.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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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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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625