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 18/736,628
Claims 1-39 are currently pending.
Priority
Instant application 18/736,628, filed 6/7/2024, claims priority as follows:
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Support for the instant claims is found in the provisional application.
Information Disclosure Statement
All references from the IDS’s submitted on 3/23/2026 and 8/21/2026 have been considered unless marked with a strikethrough. The Examiner notes the SciFinder references struck through on the IDS submitted 3/23/2026 were not able to be matched to submitted documents, and the other references struck through were not submitted in the file wrapper.
Objection to Abstract
The abstract is objected to because there are two different abstracts submitted that are vastly different. The abstract submitted on 6/7/2024 appears to be more in line with the current application when compared to the abstract submitted on 3/23/2026; however, it is unclear which abstract should be considered part of the application. Appropriate correction is required.
Election/Restriction
Applicant’s election of Group I, claims 1-23, drawn to compounds and compositions of Formula (I), without traverse in the reply filed 8/21/2026 is acknowledged. Applicant’s election of Example 1:
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In the same reply, is also acknowledged.
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 103 rejection below. During the search, additional prior art was identified, and the search was expanded to the full scope of instant Formula (I). Claims 1-23, Group I, are thus the subject of this Office Action. Claims 24-39 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 Interpretation
Claim 22 recites, “wherein the compound or salt is a blood brain barrier penetrant”, which is considered a functional limitation because it recites what the compound or salt does, not what it is. If the prior art meets the structural limitations of a compound or salt of Formula (I) of claim 1, the claim from which 22 depends, then the functional limitations would flow from embodiments meeting the structure. The functional limitations do not further limit the structure, and thus are not granted patentable weight.
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.
Claim 22 is 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. As stated in the “Claim Interpretation” section above, claim 22 recites a functional limitation that does not further limit the structure of claim 1, the claim from which claim 22 depends. Appropriate correction is required.
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 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 1-4, 6, 8-9, 13, 17, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Incyte Corporation (WO 2021/072232 A1, cited in the IDS of 3/23/2026, herein after “Incyte ‘232”) in further view of Shenzhen Ionova Life Science Co., LTD (WO 2024/067820 A1, herein after “Ionova”). The Examiner notes that the Ionova document qualifies as prior art because the priority date of Ionova is before that of the effective filing date of the instant claims, and the provisional application of Ionova contains support for the prior art rejection. This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Incyte ‘232 teaches bicyclic amines that are inhibitors of CDK2 (abstract) of Formula (I) (page 234, claim 1):
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And specifically teaches compounds such as Example 14 (page 154):
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Example 14 partially maps to the instant Formula (I):
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When Z is N and R2 is C3 alkyl. Example 14 differs from the elected species, and a compound of instant Formula (I) in general, by the presence of a methylsulfonyl piperidine instead of a tetrahydropyran. Further, Example 14 was placed in DMSO for biological assays (page 230), constituting a pharmaceutical composition, and was found to have inhibitory activity in CDK2/Cyclin E1 HTRF Enzyme activity assays (page 231, Table 8).
The reference Ionova teaches tricyclic compounds as CDK inhibitors (abstract), and specifically teaches compounds such as Example 6 (page 24):
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And Example 107 (page 57):
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Which solely differ from each other by the methylsulfonyl piperidine and tetrahydropyran attached to the core by an amine linker. Both compounds were found to have an IC50 of ≤ 10 nm in CDK2 inhibitory assays (page 59 and 61).
Ascertaining the differences between the prior art and the claims at issue
The reference Incyte ‘232 fails to teach compounds with a tetrahydropyran in place of the methylsulfonyl piperidine.
The reference Ionova fails to teach compound with the triazolopyrimidine core.
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 CDK2 inhibitors. An artisan possesses the technical knowledge necessary to make adjustments to the inhibitors to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said CDK2 inhibitors 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 to one having ordinary skill in the art to substitute the methylsulfonyl piperidine moiety of Example 14 of Incyte ‘232 with the tetrahydropyran moiety of Example 107 of Ionova because Ionova teaches that the methylsulfonyl piperidine and tetrahydropyran moieties attached to the core of CDK2 inhibitors by an amine linker are interchangeable. All three compounds are known to have inhibitory activity against CDK2 inhibitors, and structurally similar compounds are expected to have similar properties. A skilled artisan would have been motivated before the effective filing date to make such as substitution to identify additional compounds capable of inhibiting CDK2, and ultimately treat diseases associated with CDK2 activity. Further, one of ordinary skill would have reasonably predicted success in light of the teachings of Incyte ‘232 and Ionova.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Incyte Corporation (WO 2021/072232 A1, cited in the IDS of 3/23/2026, herein after “Incyte ‘232”) in further view of Shenzhen Ionova Life Science Co., LTD (WO 2024/067820 A1, herein after “Ionova”). The Examiner notes that the Ionova document qualifies as prior art because the priority date of Ionova is before that of the effective filing date of the instant claims, and the provisional application of Ionova contains support for the prior art rejection. This rejection applies to the full scope of instant Formula (I).
Determining the scope and contents of the prior art
The reference “Incyte ‘232” teaches as disclosed above, and at least those teachings are incorporated herein. Further, with respect to claims 5, 7, 10-12, 14-16, and 18-19, Incyte ‘232 teaches the genus of Formula (I) (page 234):
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Which when p is 0, ring A is a 5-membered heteroaryl, X is C, Y is N, and thus the ring is
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, and n is 0, overlaps with instant Formula (I) and compounds of the instant disclosure. The genus of Formula (I) of Incyte ‘232 teaches that Z can be N or CR2, where R2 can be H, which overlaps with instant Formula (I), and further directs a skilled artisan to make this choice by compounds such as Example 14 above, where Z is N, and Example 2, where Z is CR2 and R2 is H:
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Further, Incyte ‘232 teaches that the variable R1 of Formula (I) can be ORa1, where Ra1 can be C1-6 alkyl and C1-6 haloalkyl, which overlaps with the genus and compounds of the instant disclosure. A skilled artisan would be directed to make this choice from compounds such as Example 9 (page 151):
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And further teachings of exemplary haloalkyl groups include CF3 and CHF2, and the like (page 70, lines 20-26).
The reference Ionova teaches as disclosed above and at least those teachings are incorporated herein.
Ascertaining the differences between the prior art and the claims at issue
The reference Incyte ‘232 fails to teach compounds with a tetrahydropyran in place of the methylsulfonyl piperidine, and thus fails to teach anticipatory species with specific N and CH core substitutions in combination with alkyl and haloalkyl functional groups recited in the instant claims.
The reference Ionova fails to teach compounds with the triazolopyrimidine core.
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 CDK2 inhibitors. An artisan possesses the technical knowledge necessary to make adjustments to the inhibitors to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said CDK2 inhibitors 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 to one having ordinary skill in the art to substitute the methylsulfonyl piperidine moiety of the compounds of Incyte ‘232 with the tetrahydropyran moiety of Example 107 of Ionova because Ionova teaches that the methylsulfonyl piperidine and tetrahydropyran moieties attached to the core of CDK2 inhibitors by an amine linker are interchangeable. All of the compounds are known to have inhibitory activity against CDK2 inhibitors, and structurally similar compounds are expected to have similar properties. A skilled artisan would have been motivated before the effective filing date to make such as substitution to identify additional compounds capable of inhibiting CDK2, and ultimately treat diseases associated with CDK2 activity. Further, one of ordinary skill would have reasonably predicted success in light of the teachings of Incyte ‘232 and Ionova.
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 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27, 30-35, and 38-40 of copending Application No. 19/348,091 (herein after the “’091 Application” in view of Shenzhen Ionova Life Science Co., LTD (WO 2024/067820 A1, herein after “Ionova”).
The claims of the ’091 Application recite the genus of Formula (I) (page 234):
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Which when p is 0, ring A is a 5-membered heteroaryl, Z is N or CR2, where R2 is H, R1 is ORa1, where Ra1 is C1-4 alkyl or C1-4 haloalkyl, X is C, Y is N, and thus the ring is
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, and n is 0, overlaps with instant Formula (I) and compounds of the instant disclosure. Further, the ’091 Application recites a pharmaceutical composition comprising a compound of Formula (I) and a pharmaceutically acceptable carrier.
The reference Ionova teaches as disclosed above, and at least those teachings are incorporated herein.
However, the ’091 Application fails to teach a genus or compounds with a tetrahydropyran in place of the methylsulfonyl piperidine, and the reference Ionova fails to teach compounds with the triazolopyrimidine core.
Applying KSR prong (B), it would have been prima facie obvious to one having ordinary skill in the art to substitute the methylsulfonyl piperidine moiety of the the ’091 Application with the tetrahydropyran moiety of Example 107 of Ionova because Ionova teaches that the methylsulfonyl piperidine and tetrahydropyran moieties attached to the core of CDK2 inhibitors by an amine linker are interchangeable. All of the compounds are known to have inhibitory activity against CDK2 inhibitors, and structurally similar compounds are expected to have similar properties. A skilled artisan would have been motivated before the effective filing date to make such as substitution to identify additional compounds capable of inhibiting CDK2, and ultimately treat diseases associated with CDK2 activity. Further, one of ordinary skill would have reasonably predicted success in light of the teachings of the ’091 Application and Ionova.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-23 are rejected. Claims 24-39 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.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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