Detailed Action
The present office action is in response to the reply filed on 03 Jun 2026.
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
Claims 1-2, 3-5, 8, 10-11, 14, 17, 20, 22, 24, 26, 28, 30, 32, 35, 38, 40-41, and 66 of the pending application have been examined on the merits. Claims 67-71 of the instant application are withdrawn (see “Response to Applicant Elections” below). Acknowledgement is made of the cancellation of claims 6-7, 9, 12-13, 15-16, 18-19, 21, 23, 25, 27, 29, 31, 33-34, 36-37, 39, 42-62, 64-65.
Priority
Applicants identify the instant application, Serial #: 18/577,672, filed 08 Jan 2024, as a National Stage Entry of International Patent Application #: PCT/US2022/036520, filed 08 Jul 2022, which claims priority from Provisional Application #s: 63/317,930, filed 08 Mar 2022, 63/314,994, filed 28 Feb 2022, 63/220,321, filed 09 Jul 2021, and 63/220,319, filed 09 Jul 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 08 Jan 2024 and 03 Jun 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Elections
Applicant’s election without traverse of Group I, claims 1-2, 3-5, 8, 10-11, 14, 17, 20, 22, 24, 26, 28, 30, 32, 35, 38, 40-41, and 66, in the reply filed on 03 Jun 2026 is acknowledged. Applicant further elected the following species of Formula I-A in the reply filed 03 Jun 2026:
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A search for the elected species failed to return prior art. Examiner expanded the search to encompass the genus of Formula I-A, which was found to be free of prior art. However, the claims of Group I are not in condition for allowance (see below).
Claims 67-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03 Jun 2026.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See paragraphs [0387]-[0389]
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in paragraph [0397].
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Claim Objections
Claim 63 objected to because of the following informalities: The species of compounds vary in formatting and presentation. For example, compounds in claim 63 may be identified by a name, identification number, structure, or a Diastereomer or Enantiomer tag. Examiner respectfully requests applicant standardize the formatting of compound structures of claim 63. Appropriate correction is required.
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 2, 5, 14, 17, 20, 22, 24, 26, 28, 30, 32, 35, 38, and 40-41 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.
Regarding claims 2, 5, 14, 17, 20, 22, 24, 26, 28, 30, 32, 35, 38, and 40, claims 2, 5, 14, 20, 24, 28, 32, 35, and 38 contain the limitation of Ring B. However, there is a lack of antecedent basis for this variable. Claims 17, 22, 26, 30, and 40 are rejected for failing to remedy the deficiencies of claims 2, 5, 14, 20, 24, 28, 30, 32, 35, and 38. Applicant may overcome this rejection by amending the claims to include a definition of Ring B.
Regarding claim 41, the claim is directed towards a compound of Formula I-B:
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Where s40 is 1 when r40 is 0. However, it is unclear how the bond between X40 and the carbon at position 3 of the piperidone moiety is formed when carbon already has four bonds to carbons at positions 2, 4, and 5 of the piperidone moiety when r40 is 0. There is nothing in the claim to indicate that when r40 is 0, the bond between the 3-position carbon and 5-position carbon has been removed. It would therefore be unclear how carbon forms 5 bonds to include X40 when r40 is 0, and so the claim is indefinite.
Allowable Subject Matter
Claims 1, 3-4, 8, 10-11, and 66 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: There is no art which teaches or suggests the compounds of Formula I-A or a pharmaceutical composition comprising a compound of Formula I-A and a pharmaceutically acceptable carrier:
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The following references are considered the closest art to the instant claims: Sievers et al. (Science, 2018, 362:eaat0572), hereinafter Sievers, WO 2020/012334 (provided in IDS 01/08/24), hereinafter ‘334, WO 2020/012337 (provided in IDS 01/08/2024), hereinafter ‘337, and U.S. Patent No 11,878,868, hereinafter ‘868.
Sievers teaches compounds useful for targeting and degrading IKZF1 and IKZF3 which include thalidomide, lenalidomide, and pomalidomide (pg. 1, column 1). Sievers also teaches thalidomide analogs CC-122, CC-220, and CC-885 target IKZF proteins (pg. 8, column 1), but does not teach the compounds of the instant Formula I-A.
‘334 and ‘337 both teach compounds with utility as IKZF2 inhibitors. ‘334 teaches compounds with the core structure (pg. 3):
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‘337 teaches compounds with the core structure (pg. 3):
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The main difference between the compounds taught by the reference and the instant claims is the instant Q variable, which does not have an analog in the reference disclosures. Further, there is no art which would suggest adding the Q moiety to the compounds taught by ‘334 and ‘337. Therefore, the claims are novel over the art.
It is further noted that the instant claims are patentably distinct from the compounds claimed in ‘968, the difference being the Q variable which does not allow for aryl or heteroaryl groups. The equivalent group found in ‘968 is an aryl group and so the claims are distinct.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kunnumakkara et al. (Exp Biol Med, 2019; 244:663-689) is considered pertinent for teaches the variability in types of cancers and causes of cancer. Gura et al. (Science, 1997, 278:1041-1042) is considered pertinent for teaching the unpredictability of finding a viable anticancer therapeutic. Johnson et al. (Br J Cancer, 2001, 84:1424-1431) is considered pertinent for teaching the inherent unpredictability in translating cancer models into human treatment. Xia et al., (Front Mol Biosci, 2021, 8:788440) is considered pertinent for teaching which cancers the IKZF protein, Ikaros, may be a viable target for.
Conclusion
Claims 1, 3-4, 8, 10-11, and 66 are allowable as written. Claims 2, 5, 14, 17, 20, 22, 24, 26, 28, 30, 32, 35, 38, and 40-41 are not allowed. Claims 67-71 are withdrawn.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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