NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jul. 15, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 2-7, 11, 13-44, 49-52, and 67 have been canceled.
Claim 1 has been amended and incorporates no new matter.
No new claims have been added.
Claims 8-10, 12, 46-48, 63-66, and 71 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 1, 45, 53-62, and 68-70 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on Oct. 1, 2026 was filed after the mailing date of the non-final action on Apr. 16, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
RESPONSE TO AMENDMENTS & ARGUMENTS
The amendments to the claims overcome the rejections under 35 U.S.C. § 112(b) and 35 U.S.C. § 102. Therefore, these rejections have been withdrawn.
Applicant’s arguments, see Remarks, pp. 8-10, filed Jul. 15, 2026, with respect to the rejections under 35 U.S.C. § 103 and on the ground of obviousness-type double patenting have been fully considered and are persuasive. Therefore, these rejections have been withdrawn.
However, upon further consideration, new grounds of rejection are made in view of Shafer et al. and/or Delmore et al., as set forth below.
NEW REJECTIONS
Claim Rejections - 35 U.S.C. § 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, 45, 53-62, and 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US Pub. 2016/0256468, of record) in view of Delmore et al. (Cell 146, 904–917 (2011), cited on PTO-892).
Schafer et al. disclose and claim methods of treating myeloma comprising administering to a patient a therapeutically effective amount of the elected compound, iberdomide (a.k.a. Compound 5, 3-(4-((4-(morpholinomethyl)benzyl)oxy)-1-oxoisoindolin-2-yl)piperidine-2,6-dione) (compounds (I), (I-R), (I-S); claim 1),
wherein the myeloma is multiple myeloma (claim 4),
wherein the multiple myeloma is relapsed or refractory (claim 12),
wherein the multiple myeloma is drug-resistant (claim 13),
wherein the multiple myeloma is resistant to lenalidomide (claim 65),
wherein the patient has been newly diagnosed with multiple myeloma (para. [0351]),
further comprising the administration of a therapeutically effective amount of one or more additional active agents (claim 30; paras. [0178]-[0180], [0251]-[0257]),
as recited by claims 1, 45, and 53-62.
Schafer et al. differs from the claims in that the reference does not disclose an inhibitor of PLK1, BRD4, BET, NEK2, AURKB, MEK, PHF19, BTK, mTOR, PIM, IGF-1R, XPO1, DOT1L, EZH2, JAK2, or BIRC5 as a second active agent, as recited by claim 1; and does not disclose the elected BRD4/BET inhibitor JQ-1, as recited by claims 68-70.
However, treating multiple myeloma by administering JQ-1 was known in the prior art.
For example, Delmore et al. disclose that JQ-1, a selective inhibitor of BRD4/BET, is effective against multiple myeloma. In experimental models of multiple myeloma, JQ1 produces a potent antiproliferative effect associated with cell cycle arrest and cellular senescence (p. 904, left col.). Specifically, administration of JQ1 reduces tumor burden in both subcutaneous and orthotopic myeloma xenografts, and prolongs survival of mice bearing disseminated myeloma. In a transgenic model, administration of JQ-1 for 14 days reduces tumor-derived immuno-globulin (M-protein), including a complete response in one animal (Figs. 6-7).
Delmore et al. conclude that efficacy of JQ1 in three murine models of multiple myeloma establishes the therapeutic rationale for BET bromodomain inhibition in malignancies characterized by pathologic activation of c-Myc, including multiple myeloma (p. 904, left col.).
Thus, Delmore et al. disclose a method of treating multiple myeloma by administering the BRD4/BET inhibitor JQ-1, as recited by claims 68-70.
It would have been predictable to one of ordinary skill in the art as of the filing date to combine (1) the treatment of multiple myeloma by administering iberdomide with a second active agent, as taught by Schafer et al., with (2) the treatment of multiple myeloma by administering the BET/BRD4 inhibitor JQ-1, as taught by Delmore et al., with a reasonable expectation of success, because the elected compound species, iberdomide and JQ-1, were each separately known to be effective for treating the same disease. Thus, their combination would also be expected to effectively treat multiple myeloma.
As recognized by MPEP §2144.06, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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, 45, 53, and 68-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-7 and 13 of U.S. Patent No. 10,596,180;
claims 1-7 and 13 of U.S. Patent No. 10,463,672;
claims 1-28 and 34 of U.S. Patent No. 9,884,062; and
claims 1-36 and 41 of U.S. Patent No. 9,629,849,
in view of Delmore et al. (Cell 146, 904–917 (2011), cited on PTO-892).
The '180 reference claims are drawn to methods of treating cancer in a subject, comprising administering to the subject a therapeutically effective amount of a solid crystalline polymorphic form of iberdomide, wherein the cancer is multiple myeloma.
The '672 reference claims are drawn to methods of treating cancer in a subject, comprising administering to the subject a therapeutically effective amount of a solid crystalline polymorphic form of iberdomide, wherein the cancer is multiple myeloma.
The '062 reference claims are drawn to methods of treating cancer in a subject, comprising administering to the subject a therapeutically effective amount of a solid crystalline polymorphic form of iberdomide, wherein the cancer is multiple myeloma.
The '849 reference claims are drawn to methods of treating cancer in a subject, comprising administering to the subject a therapeutically effective amount of a solid crystalline polymorphic form of iberdomide, wherein the cancer is multiple myeloma.
The reference claims differ from the examined claims in that the reference claims do not recite the co-administration of a second active agent, e.g., the elected BRD4/BET inhibitor JQ-1.
However, treating multiple myeloma by administering JQ-1 was known in the prior art.
For example, Delmore et al. disclose that JQ-1, a selective inhibitor of BRD4/BET, is effective against multiple myeloma. In experimental models of multiple myeloma, JQ1 produces a potent antiproliferative effect associated with cell cycle arrest and cellular senescence (p. 904, left col.). Specifically, administration of JQ1 reduces tumor burden in both subcutaneous and orthotopic myeloma xenografts, and prolongs survival of mice bearing disseminated myeloma. In a transgenic model, administration of JQ-1 for 14 days reduces tumor-derived immuno-globulin (M-protein), including a complete response in one animal (Figs. 6-7).
Delmore et al. conclude that efficacy of JQ1 in three murine models of multiple myeloma establishes the therapeutic rationale for BET bromodomain inhibition in malignancies characterized by pathologic activation of c-Myc, including multiple myeloma (p. 904, left col.).
Thus, Delmore et al. disclose a method of treating multiple myeloma by administering the BRD4/BET inhibitor JQ-1, as recited by examined claims 68-70.
It would have been predictable to one of ordinary skill in the art as of the filing date to combine (1) the treatment of multiple myeloma by administering iberdomide, as recited by the reference claims, with (2) the treatment of multiple myeloma by administering the BET/BRD4 inhibitor JQ-1, as taught by Delmore et al., to arrive at the methods of the examined claims with a reasonable expectation of success, because the elected compound species, iberdomide and JQ-1, were each separately known to be effective for treating the same disease. Thus, their combination would also be expected to effectively treat multiple myeloma.
As recognized by MPEP §2144.06, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
Abruzzese et al. Cell Death and Disease 10:324 (2019) and Diaz et al. Haematologica, Volume 102(10):1776-1784 (2017) (both cited on PTO-892).
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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
Prosecution Insights