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
Claims 111-144 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group 1 (Claims 111-144, drawn to Compounds of Formulae I, II, II-1, and II-2) and the elected species
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in the reply filed on 1/23/2026 is acknowledged.
Claims 142-143 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to unelected species, there being no allowable generic or linking claim. Thus, Claims 111-141 and 144 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
Claim Objections
Claim 123 is objected to because of the following informalities:
R1 is defined twice. One of the duplicate definitions should be removed.
Appropriate correction is required.
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.
Claim Rejections - 35 USC § 102
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 person shall be entitled to a patent unless –
(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.
Claims 111, 113-116, 118, 120-122, and 144 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindenthal (US20060252748).
Lindenthal teaches CDK inhibitors (Abstract). Lindenthal teaches compound 145 as a CDK inhibitor on Page 35:
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, in which the following definitions of examined Formula I apply: X is N; R3 is Br; R4 is H; L1 is
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, wherein n is 0; R1 is SO2NH2; L2 is a bond; L3 is a 1-membered heteroalkylene, NH2; and R2 is
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. Compounds of the inventions are to be formulated with various excipients in various dosage forms, or pharmaceutical compositions (Para 100-105).
Claims 111, 113-114, 117-118, 120-122 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Behenna (US20180044344, 11/03/2023 IDS).
Behenna teaches the following intermediate in the synthesis of example 6 (Page 56, Para 1010):
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((±)-(lR*,2R*)-2-[(5-bromo-2-{[l- (methylsulfonyl)piperidin-4-yl]amino}pyrimidin-4-yl) amino]-l-methylcyclopentanol), in which the following definitions of examined Formula I apply: X is N; R3 is Br; R4 is H; L1-R1 is
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; L2 is a bond; L3 is a 1-membered heteroalkylene, NH2; and R2 is
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.
Claims 123-124 and 128-131 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Finlay (WO2009022171).
Finlay teaches ALK5 inhibitors (Abstract). Finaly teaches Example 117 on Page 128:
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, in which the following definitions of examined Formula II apply: X is CR13, wherein R13 is H; R3 and R4 are both H; L1-R1 is
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; L2 is O; L3 is a bond; Ring A is a methyl substituted heteroarylene/heterocyclylene; and Q is a C1 alkyl, methyl.
Claim Rejections - 35 USC § 103
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.
Claims 1, 113-124, 126, 129-132, 134, 136-138, and 144 are rejected under 35 U.S.C. 103 as being unpatentable over Lindenthal (US20060252748).
Lindenthal teaches CDK inhibitors (Abstract). Lindenthal teaches compound 145 as a CDK inhibitor on Page 35:
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, in which the following definitions of examined Formula I apply: X is N; R3 is Br; R4 is H; L1 is
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, wherein n is 0; R1 is SO2NH2; L2 is a NH2 ; L3 is a bond; and R2 is
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. Compounds of the inventions are to be formulated with various excipients in various dosage forms, or pharmaceutical compositions (Para 100-105).
Lindenthal teaches that the instant L2 position—X in formula I of Lindenthal—may instead be an oxygen (Para 16). One of skill in the art seeking to form CDK inhibitors would find it obvious to make the modification to Compound 145 using the alternative embodiment to position X as suggested by Lindenthal before the filing date of the instant application. The same artisan would expect the successful modification of the compound because of the limited acceptable embodiments of X and Lindenthal teaching that compounds of the genus of formula I, including a modified Compound 145, are acceptable CDK inhibitors.
Claims 111-116, 118-122, and 144 are rejected under 35 U.S.C. 103 as being unpatentable over Lindenthal (US20060252748).
Lindenthal teaches CDK inhibitors (Abstract). Lindenthal teaches Compound 144 as a CDK inhibitor on Page 35:
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, in which the following definitions of examined Formula I apply: X is N; R3 is Br; R4 is H; L1 is
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, wherein n is 0; R1 is SO2NH2; L2 is O; L3 is a bond; and R2 is
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. Compounds of the inventions are to be formulated with various excipients in various dosage forms, or pharmaceutical compositions (Para 100-105).
Lindenthal teaches that the instant R2 position—also R2 in formula I of Lindenthal—may be C1-C10 cycloalkyl (interrupted by O) (Para 14). One of skill in the art seeking to form CDK inhibitors would find it obvious to expand the 6-membered heteroalkyl,
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, to yield the R2,
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, as claimed. The same artisan would expect the successful modification of the compound because Lindenthal teaches that compounds of the genus of formula I, including a modified Compound 144, are acceptable CDK inhibitors. Further, Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
Claims 132-134 and 136-138 are rejected under 35 U.S.C. 103 as being unpatentable over Lindenthal (US20060252748).
Lindenthal teaches CDK inhibitors (Abstract). Lindenthal teaches Compound 144 as a CDK inhibitor on Page 35:
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, in which the following definitions of examined Formula I apply: X is N; R3 is Br; R4 is H; L1 is
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, wherein n is 0; R1 is SO2NH2; L2 is O; L3 is a bond; and R2 is
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. No equivalent Q substituent is taught.
Lindenthal teaches R2—also R2 in the equivalent position of formula I in Lindethal—may be substituted by “halogen, hydroxy, C1-C6- alkyl, C1-C6-alkoxy”, among others (Para 14). Any of the above substituents added to a carbon adjacent to the ester linkage would render the compounds of Formulae II-1 and II-2 obvious. One of skill in the art seeking to form CDK inhibitors before the filing date of the claimed invention would find it obvious to substitute the R2 ring as taught by Lindenthal. One would expect success in doing so because the modification is explicitly suggested by Lindenthal to form CDK inhibitors of formula I. Further, regarding the exchange of an H for CH3 (or CH2H) specifically, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
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.
PROVISIONAL:
1. Claims 111-141 and 144 are provisionally rejected on the grounds of anticipatory nonstatutory double patenting as being unpatentable over Claims 17-38 of copending Application No. 18670469 (hereinafter referred to as Allorion).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to the same compounds and pharmaceutical compositions thereof. For example, both applications teach the elected species:
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.
Method claims require the existence of the claimed compounds.
Since both applications teach the same species, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Allorion.
This is a provisional nonstatutory double patenting rejection.
2. Claims 111-140 and 144 are provisionally rejected on the grounds of anticipatory nonstatutory double patenting as being unpatentable over Claims 1-41 of copending Application No. 18958484 (hereinafter referred to as Allorion).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to overlapping genera of kinase inhibitors and pharmaceutical compositions thereof. Allorion teaches more narrow genera of Formulae I, II, II-1, and II-2, where R10 in particular is limited to aromatic carbocycles and heterocycles. The same compounds are also taught; e.g.,
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(Claim 34). Methylene homologs are also taught:
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(instant Claim 140) vs.
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(copending Claim 39). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
Method claims require the existence of the claimed compounds.
Since both applications teach overlapping genera, similar compounds, and the same compounds, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Allorion.
This is a provisional nonstatutory double patenting rejection.
3. Claims 111-138 and 144 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-31 of copending Application No. 19431098 (hereinafter referred to as Allorion).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to inhibitor isotopes and compositions thereof.
Allorion teaches deuterated isotopes of the elected species, wherein the isotope is not the elected species of the instant application. However, Allorion teaches any of the three deuterium may instead be hydrogen. The substitution taught by Allorion at any of the deuterium of the elected species would render obvious the claims of the instant application.
Method claims require the existence of the claimed genera of formulae.
Since both applications teach inhibitor isotopes, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Allorion.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights