Detailed Action
The present office action is in response to the reply filed on 05 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, 3, 5-6, 8-9, 13, 15-17, 21, 24, and 27 of the pending application have been examined on the merits. Claims 28-32 of the instant application are withdrawn (see “Response to Applicant Elections” below). Acknowledgement is made of the cancellation of claims 2, 4, 7, 10-12, 14, 18-20, 23, and 25-26.
Priority
Applicants identify the instant application, Serial #: 18/577,674, filed 08 Jan 2024, as a National Stage Entry of International Patent Application #: PCT/US2022/036527, filed 08 Jul 2022, which claims priority from Provisional Application #s: 63/322,162, filed 21 Mar 2022, 63/272,858, filed 28 Oct 2021, and 63/220,317, filed 09 Jul 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 08 Jan 2024, 13 Aug 2024, and 05 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 in the reply filed on 05 Jun 2026 is acknowledged. Applicant further elected the following species of Formula I 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, which was found to be free of prior art. However, the claims of Group I are not in condition for allowance (see below).
Claims 28-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 05 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 [0230]-[0232]
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 [0239].
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 1 is objected to because of the following informalities: in the definition when Z is CR1, the phrase “nitrogen ,or sulfur…” should be “nitrogen, or sulfur…” Appropriate correction is required.
Claim 24 is objected to because of the following informalities: The presentation of compounds vary in formatting. Examiner respectfully requests applicant standardize the formatting of compound structures of claim 24. 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 1, 3, 5-6, 8-9, 13, 15- 17, 21, and 27 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.
Claim 1 is directed towards a compound of Formula I:
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Where s is 1 when r is 0. However, it is unclear how the bond between X 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 r is 0. There is nothing in the claim to indicate that when r 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 X when r is 0, and so the claim is indefinite. Claims 3, 5-6, 8-9, 13, 15-17, 21, and 27 are rejected for failing to remedy the deficiencies of claim 1. Applicant may overcome this rejection by amending the claims to clarify how carbon has 5 bonds when s is 1.
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, 5-6, 8, 13, 15-17, 21, 24, and 27 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 11,878,968, hereinafter ‘968, in view of Lovering et al. (J Med Chem, 2009, 52:6752-6756), hereinafter Lovering.
The instant claims are drawn to compounds of Formula I, where R3 is limited to optionally substituted C3-C10 cycloalkyl:
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‘968 claims a compound selected from:
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‘968 further claims a pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound selected from claim 1 (claim 10). However, ‘968 differs from the instant claims in having a phenyl group in place of the C3-C10 cycloalkyl of the instant R3.
Lovering teaches that carbon bond saturation increases complexity of molecules and that changing saturation allows for the preparation of diverse chemical species without increasing molecular weight significantly and access to significantly more isomers (pg. 6752, column 2). Lovering further teaches that saturation of compounds increases likelihood of higher solubility and lower melting points (pg. 6755, column 1).
MPEP § 2144.09(I) states, “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities.”
Based on the teachings of ‘968 and Lovering, it would be prima facie obvious to the person of ordinary skill in the art that the compounds of ‘968, when the phenyl groups are saturated, would be of sufficiently close structure to the compounds of the instant claims. The motivation to make the instant compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active IKZF2 modulators) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘968.
Claims 1, 3, 5-6, 8, 13, 15-17, 21, 24, and 27 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 32 and 39 of copending Application No. 18/496,709, hereinafter ‘709, in view of Lovering.
The instant claims are drawn to compounds of Formula I, where R3 is limited to optionally substituted C3-C10 cycloalkyl:
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‘709 claims a compound selected from:
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‘709 further claims a pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound selected from claim 32 (claim 39). However, ‘709 differs from the instant claims in having a phenyl group in place of the C3-C10 cycloalkyl of the instant R3.
Lovering teaches that carbon bond saturation increases complexity of molecules and that changing saturation allows for the preparation of diverse chemical species without increasing molecular weight significantly and access to significantly more isomers (pg. 6752, column 2). Lovering further teaches that saturation of compounds increases likelihood of higher solubility and lower melting points (pg. 6755, column 1).
MPEP § 2144.09(I) states, “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities.”
Based on the teachings of ‘709 and Lovering, it would be prima facie obvious to the person of ordinary skill in the art that the compounds of ‘709, when the phenyl groups are saturated, would be of sufficiently close structure to the compounds of the instant claims. The motivation to make the instant compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active IKZF2 modulators) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compound in view of the compounds taught by ‘709.
This is a provisional nonstatutory double patenting rejection.
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
No claim is allowed.
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.
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, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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