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 of Claims
Claims 72-90 are pending in the instant application.
Claims 1-71 have been canceled.
Claims 76-79 stand withdrawn.
Withdrawn Objections/Rejections
Applicant’s cancellation of Claims 2, 4-5, 63-71 and the amendment to Claim 74 renders the rejection thereof on the basis that it contains an improper Markush grouping of alternatives moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 2, 4-5, 63-71, and the amendment to Claim 74 renders the rejection thereof under 35 U.S.C. 112(a) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 70 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 2, 4-5, 63, 65, 67, and 68-71 renders the rejection thereof on the ground of nonstatutory double patenting moot. This rejection is hereby withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed March 27th, 2026 has been fully considered by the examiner, except where marked with a strikethrough.
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.
The rejection of Claims 72-75 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. 12,286,427 is maintained and extended to newly presented Claims 80-81 and 84-90. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and Claims 1 and 15 are drawn to an overlapping set of compounds and pharmaceutical compositions thereof.
In the remarks filed March 27th, 2026, Applicant traversed this rejection on the basis that the spirocyclic element in the instantly claimed compounds is missing in claims 1 and 15 of U.S. Patent No. ‘427. Further, Applicant states that “claims 1 and 15 of the ‘427 patent generically recite a 3-12 membered heterocycloalkyl. Such a generic recitation does not constitute a suggestion or even the slightest hint for the instantly claimed spirocyclic heterocycloalkyl.”
The examiner does not find this persuasive. U.S. Patent No. ‘427 defines the term “heterocycloalkyl” at Column 65, Second Paragraph. At Column 65, Lines 14-15, U.S. Patent No. ‘427 states, “In some embodiments, a heterocycloalkyl ring is a spirocyclic heterocycloalkyl ring.” Therefore, the limitation recited at Claim 1 of “3-12 membered heterocycloalkyl ring” includes spirocyclic rings as instantly claimed. Specific examples of how instantly claimed compounds read on the patented Claim 1 of U.S. Patent No. ‘427 were presented in the non-final rejection mailed December 30th, 2025. For clarity of the record, these examples are revisited here.
For example, the following compound, instantly recited at the fourth row, second compound of Claim 72 is:
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This compound is also recited at Claim 80, fourth line, second compound.
This compound reads on a compound of Claim 1 of U.S. Patent ‘427 when the variables are defined as follows:
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is an 8-membered heterocycloalkyl ring, wherein the heterocycloalkyl ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with two R10, wherein one R10 is methyl, and the other R10 is -C(O)R15 is C2-heteroaryl, further substituted by one R20f, wherein R20f is halogen, wherein the halogen is bromine.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Similarly, at the second line, first compound of Claim 73, the following compound is claimed:
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This compound is also recited at Claim 80, at Page 8, Last Line, Second compound.
This compound is also recited as the second compound at Claim 81.
This compound is also recited at Claim 85.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is a 10-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with one R10, wherein R10 is -C(O)R15. Wherein R15 is C2-heteroaryl.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Further, Claim 72, at Page 3, Last Line, First Compound recites the following compound:
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This compound is also recited at Claim 73, Second Line, Second Compound.
This compound is also recited at Claim 80, Page 8, Fourth Line, First Compound.
This compound I also recited as the first compound at Claim 81.
This compound is also recited at Claim 84.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is a 9-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with one R10, wherein R10 is -C(O)R15. Wherein R15 is C2-heteroaryl.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Further, Claim 72, at Page 4, Line 4, Second Compound, recites the following compound:
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This compound is additionally recited at Claim 80, Page 9, Second Line, First Compound.
This compound is additionally recited at Claim 86.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is an 8-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with three R10, wherein R10 is -C(O)R15. Wherein R15 is C3-cycloalkyl further substituted by two R20f, wherein each R20f is halogen, wherein halogen is fluorine, and the other two R10 are halogen, wherein halogen is fluorine.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Further Claim 72, at Page 5, Second Line, First compound, recites the compound of the formula:
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This compound is additionally recited at Claim 73, Second Line, Third Compound.
This compound is additionally recited at Claim 80, Page 9, Third Line, Second compound.
This compound is additionally recited at Claim 87.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is an 11-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with one R10, wherein R10 is -C(O)R15. Wherein R15 is C2-heteroaryl.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Further, at Claim 72, Page 4, Line 3, Second Compound, the following compound is recited:
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This compound is additionally recited at Claim 88.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is a 10-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with one R10, wherein R10 is -C(O)R15. Wherein R15 is C2-heteroaryl.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Further, Claim 72 at Page 4, Third Line, Third Compound, the following compound is recited:
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This compound is additionally recited as the last compound of Claim 73.
This compound is additionally recited at Claim 89.
This compound reads on a compound of Claim 1 of U.S. Patent No. ‘427 when the variables are defined as follows:
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is a 10-membered heterocycloalkyl ring, wherein the ring is a spirocyclic heterocycloalkyl ring as defined at Column 65, Second Paragraph, further substituted with one R10, wherein R10 is -C(O)R15. Wherein R15 is C2-heteroaryl.
L1 is a bond.
R1a is halogen, wherein halogen is fluorine.
R1b and R1c are each hydrogen.
R1d is -CN.
R8 is halogen, wherein halogen is chlorine.
R12 is -CH2-C7-heterocycloalkyl, further substituted by one R20d, wherein each R20d is halogen, wherein halogen is fluorine.
R16 is halogen, wherein halogen is fluorine.
Claim 15 of U.S. Patent No. ‘427 is drawn to a pharmaceutical compound comprising the compound s of Claim 1 of U.S. Patent No. ‘427. Therefore, instant Claims 74-75 and 90 read on Claim 15 of U.S. Patent No. ‘427.
Allowable Subject Matter
Claims 82-83 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 72-75, 80-81, and 84-90 are rejected.
Claims 82-83 are objected to.
Claims 76-79 stand withdrawn.
THIS ACTION IS MADE FINAL. 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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