NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/CN2022/141113, filed Dec. 22, 2022, which claims benefit of foreign priority to CN 202111599314.4, filed Dec. 24, 2021.
Claims 1-3, 8, 10-13, 16, 20, 22, 23, 26, 28-33, and 37, as amended, are pending.
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 .
Priority
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Jun. 21, 2024, Feb. 3, 2026, and Jun. 12, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, drawn to compounds and compositions of formula (I0), and compound A80 as the compound species, having the structural formula,
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in the reply filed on Jul. 10, 2026, is acknowledged.
Compound A80 reads on formula (I0) as recited by claims 1, 2, 10-13, 16, 20, 22, 23, 32, and 33; formula (I) as recited by claims 3, 26, and 28-31; and formula (I-A) as recited by claim 26, wherein:
T2 and T3 are O;
G is hydrogen;
A1 and A2 are CH2 and A3 is CH, or A1 is CH and A2 and A3 are CH2;
L2 and L3 are each a bond;
Cy3 is
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, where Q1, Q3, and Q4 are each CRQ, RQ is hydrogen, and Q2 is C; Y is C=T1, where T1 is O; and W is C(RW)2, where each RW is hydrogen;
L1 is a linking group (-CH2-NH-CH2-);
ring Z is heterocycloalkyl (piperidinyl);
Cy1 is substituted heteroaryl (pyridinyl substituted by CF3); and
Cy2 is substituted aryl (phenyl substituted by chloro), where u is 1.
Claims 8 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jul. 10, 2026.
Because the elected compound is free of the prior art, search and examination has been extended to the next species. See MPEP § 803.02.
Claims 1-3, 10-13, 16, 20, 22, 23, 26, and 28-33 are currently pending and under consideration.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the alphanumeric compound identifiers disclosed in the specification do not match those recited in claim 32; and some appear to be duplicates. For example:
Compound Number
Specification
Claim 32
A80
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A31
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A18
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Appropriate correction is required.
Claim Objections
Claims 23 and 28 are objected to because of the following informalities: the word "claim" is misspelled as "cliam." Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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 2, 3, 11-13, 16, 20, 23, 26, and 33 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Here, each of claims 2, 3, 11-13, 16, 20, 23, 26, and 33 recite definitions of variable groups of formula (I), followed by one or more "preferably" clauses, which more narrowly define the variable groups. The claims are indefinite because there is ambiguity as to whether the feature introduced by the narrower "preferably" language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP §§ 2173.05(c) and (d).
Claims 1-3, 10-13, 16, 20, 22, 23, 26, and 28-33 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.
The disclosure defines "prodrug" (para. [0103] of the published application) as follows:
The term “prodrug” will refer to a functional derivative of the compound that is readily converted to the desired compound in the body. Therefore, in the treatment methods of the present invention, the term “administer” will include the treatment of various diseases described with compounds that are specifically disclosed or with compounds that may not be specifically disclosed, but can be converted into specific compounds in vivo after administration to patients. General procedures for selecting and preparing suitable prodrug derivatives are described, for example, in “Design of Prodrugs”, edited by H. Bundgaard, Elsevier, 1985.
Thus, the specification does not define "prodrug" in limiting terms. While a "prodrug" is generally understood in the art as a compound which is therapeutically inactive until administered and metabolized to its active form, the term "prodrug" defines a genus of compounds in purely functional terms which sets no limit on the functional groups or chemical moieties which may be added to the claimed compounds to yield a "prodrug" thereof.
Thus, the scope of the compounds encompassed by the term "prodrug," and the nature of the steps required to prepare them, have no clear boundary, such that what might constitute a "prodrug" of the claimed compounds is vague and open to interpretation. Therefore, one of ordinary skill in the art could not readily distinguish compounds which are included by the claims, from compounds which are excluded.
Because a skilled artisan would not be reasonably apprised of the scope of the claimed invention, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
This rejection may be overcome by amending the claims to omit the term "prodrug."
Claims 1-3, 10-12, 16, 20, 22, 23, 26, and 33 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.
Specifically, the claims are drawn to compounds of formula (I0),
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wherein "L1 represents a linking group," without unambiguously defining the "linking group."
The disclosure defines "linking group" (para. [0250] of the published application) as follows:
Preferably, L1 is selected from a linear or branched linking group. The term “linear or branched linking group” means that the backbone of L1 does not contain a cyclic structure.
Thus, the specification fails to define the term "linking group" in sufficiently definite and limiting terms. While those skilled in the art understand what a "linking group" is, the term sets no particular boundary on the functional groups or other chemical moieties which may form a "linking group" within a compound of formula (I).
The lack of a limiting structural definition of "linking group" renders the scope of the claimed compounds ambiguous and open-ended, such that one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention. Therefore, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
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 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.
(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.
Claims 1, 10-13, 16, 22, 23, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ji et al. (WO 2020/251971, of record).
Ji et al. exemplify compound (I-106) (p. 263), having the structural formula,
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which reads on formula (I0) as recited by claims 1, 10-13, 16, 22, and 23, wherein:
T2 and T3 are O, and G is hydrogen;
A1 is CH, A2 and A3 are each CH2;
L3 is a bond;
Cy3 is methyl-substituted biheteroaryl;
L1 is a linking group (-CH2CH2CH2-O-CH2CH2-);
ring Z is unsubstituted heterocycloalkyl (piperazine);
L2 is (CHR1)k, where R1 is H and k is 1 (-CH2-);
Cy1 is unsubstituted aryl (phenyl); and
Cy2 is substituted heteroaryl (pyridazine substituted by amino and hydroxyphenyl).
The compounds of Ji et al. are disclosed in pharmaceutical compositions comprising a
pharmaceutically acceptable carrier, adjuvant, or vehicle (claim 23), as recited by claim 33.
For the foregoing reasons, Ji et al. anticipates claims 1, 10-13, 16, 22, 23, and 33.
Claims 1-3, 10-13, 16, 20, 22, 23, 26, 28-30, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Balan et al. (WO 2023/122581, cited on PTO-892).
Balan et al. exemplify compound 35 (Table 5, p. 202; claim 111), having the structural formula,
Balan et al. compound 35
Claimed Formula (I0)
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which reads on formula (I0) as recited by claims 1, 2, 10-13, 16, 20, 22, 23, and 33; formula (I) as recited by claims 3, 26, and 28-30; and formula (I-A) as recited by claim 26, wherein:
T2 and T3 are O;
G is hydrogen;
A1 and A2 are CH2 and A3 is CH, or A1 is CH and A2 and A3 are CH2;
L2 and L3 are each a bond;
Cy3 is
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, where Q1, Q3, and Q4 are each CRQ, RQ is hydrogen, and Q2 is C; Y is C=T1, where T1 is O; and W is C(RW)2, where each RW is hydrogen;
L1 is a linking group (-NH-CH2-);
ring Z is heterocycloalkyl (piperidinyl);
Cy1 is unsubstituted heteroaryl (pyridyl); and
Cy2 is hydrogen or u is 0.
The compounds of Balan et al. are disclosed in pharmaceutical compositions comprising a therapeutically effective amount of the compound, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and further comprising an additional therapeutic agent (claims 131-132), as recited by claim 33.
For the foregoing reasons, Balan et al. anticipates claims 1-3, 10-13, 16, 20, 22, 23, 26, 28-30, and 33.
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.
Claims 1-3, 10-13, 16, 20, 22, 23, 26, 28-31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Balan et al. (WO 2023/122581, cited on PTO-892).
Balan et al. exemplify compound 35 (Table 5, p. 202; claim 111), having the structural formula,
Balan et al. compound 35
Claimed Formula (I0)
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which reads on formula (I0) as recited by claims 1, 2, 10-13, 16, 20, 22, 23, and 33; formula (I) as recited by claims 3, 26, and 28-31; and formula (I-A) as recited by claim 26, wherein:
T2 and T3 are O;
G is hydrogen;
A1 and A2 are CH2 and A3 is CH, or A1 is CH and A2 and A3 are CH2;
L2 and L3 are each a bond;
Cy3 is
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, where Q1, Q3, and Q4 are each CRQ, RQ is hydrogen, and Q2 is C; Y is C=T1, where T1 is O; and W is C(RW)2, where each RW is hydrogen;
L1 is a linking group, -NR1- (-NH-CH2-);
ring Z is heterocycloalkyl (piperidinyl);
Cy1 is unsubstituted heteroaryl (pyridyl); and
Cy2 is hydrogen or u is 0.
The compounds of Balan et al. are disclosed in pharmaceutical compositions comprising a therapeutically effective amount of the compound, or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, and further comprising an additional therapeutic agent (claims 131-132), as recited by claim 33.
Compound 35 of Balan et al. differs from claim 31 in that Cy1 (pyridyl) is unsubstituted rather than, e.g., substituted by CF3 and chlorophenyl.
However, Balan et al. disclose compound 35 as a species of formula (I),
Balan et al. compound 35
Balan et al. Formula (I)
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wherein R1 is 4- to 14-membered heterocycloalkyl (piperidinyl) which may be substituted with one to four Z1, e.g., 5-10 membered heteroaryl (pyridyl), which may be substituted with one to four Z1A, e.g., C1-6 haloalkyl (e.g., CF3) and C6-10 aryl (e.g., phenyl), which may be substituted with one to four Z1B, e.g., halogen (e.g., chloro) (claim 1), as shown below:
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Modifying compound 35 as taught by Balan et al. reads on formula (I0) as recited by claim 1, and formula (I) as recited by claims 3 and 31, wherein Cy1 (pyridyl) is substituted by CF3 and chlorophenyl.
The compounds of Balan et al. are disclosed to bind to and act as degraders of IKAROS Family Zinc Finger (IKZF) proteins, such as IKZF2 (Helios) and/or IKZF4 (Eos); and are useful for the treatment of diseases and/or conditions through binding and degradation of these proteins, including cancer (abstract), which are the identical functions and uses of the claimed compounds.
Therefore, it would have been predictable to one of ordinary skill in the art as of the effective filing date to modify compound 35 as taught by Balan et al. to arrive at the claimed compounds with a reasonable expectation of success, because the close structural similarity of the prior art genus, and its teaching for the same mechanism and use as the claimed genus, create a reasonable expectation that modifying the exemplified compounds as explicitly taught and claimed by Balan et al. would exhibit similar properties, functions, and utilities.
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).
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, 10-13, 16, 20, 22, 26, 28-30, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 57 of copending Application No. 18/995,388 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because compounds recited by reference claim 57 would anticipate the examined claims.
For example, reference claim 57 recites the following compound:
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which reads on formula (I0) as recited by claims 1, 2, 10-13, 16, 20, 22, and 33; formula (I) as recited by claims 3 and 28-30; and formula (I-A) as recited by claim 26, wherein:
T2 and T3 are O;
G is hydrogen;
A1 and A2 are CH2 and A3 is CH, or A1 is CH and A2 and A3 are CH2;
L2 and L3 are each a bond;
Cy3 is
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, where Q1, Q3, and Q4 are each CRQ, RQ is hydrogen, and Q2 is C; Y is C=T1, where T1 is O; and W is C(RW)2, where each RW is hydrogen;
L1 is a linking group (-CH2-C(O)-NH-);
ring Z is heterocycloalkyl (piperidinyl);
Cy1 is substituted heteroaryl (pyridyl substituted by hydroxymethyl); and
Cy2 is unsubstituted heteroaryl (quinolinyl), where u is 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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