DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments and Status of the Claims
The amendments filed on August 21, 2026 have been acknowledged and entered. Claims 1, 143, 145-147, and 149 are pending. Claims 147 and 149 were previously withdrawn but are now rejoined (see “Election/Restrictions” section below). Claims 2-142, 144, 148, and 150-159 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2021/063761, filed on December 16, 2021. This application also claims priority to U.S. Provisional Application No. 63/126,505, filed on December 16, 2020.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant's amendments and/or remarks.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which now corresponds to claims 1, 143, 145, and 146. Applicant also elected the following species without traverse:
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and indicated that at least claims 1, 31, 51, 73, 96, 99, 102, 112, 133, 142, 145, and 146 encompass said species. The elected species was not found in the prior art and, thus, the search was expanded.
Note: Examiner previously restricted claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, 142-147, 149, 159 (“Requirement for Restriction/Election” dated September 19, 2025) into four invention groups:
Invention I (claims 1, 31, 43, 51, 70, 73, 91, 96, 99, 102, 112, 133, and 142-146), Invention II (claim 147), Invention III (claim 149), and Invention IV (claim 159). Currently, claims 1, 143, 145, and 146 correspond to Invention I; claim 147 still corresponds to Invention II; and claim 149 still corresponds to Invention III; claim 159, which originally corresponded to Invention IV, is now cancelled.
In the previous non-final rejection (dated 05/21/2026), instant claims 1, 143, 145, and 146 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6, 8-14, and 23-26 of U.S. Patent No. 11,084,825 B2 (‘825B2),
claims 1-4, 6-9, 14-17 of U.S. Patent No. 12,251,385 B2 (‘385B2),
claims 1, 2, 4-6, 8-15, 17-21, 23, 25, 26, 35, 39, 41, 43, 46, 48, 56, 59-61, and 67-83 of U.S. Patent Application No. 19/489,148 (‘148),
claims 1-3, 10, 12, 13, 23, 25, 43, 44, 47, 55, 67, 70-73 of U.S. Patent Application No. 18/865,235 (‘235), and
claims 1-23 of U.S. Patent Application No. 18/879,030 (‘030).
A terminal disclaimer has been filed with respect to:
U.S. Application No. 18/865,235 and 18/879,030 as well as
U.S. Patent No. 11,084,825 B2 and 12,251,385 B2.
Therefore, the nonstatutory double patenting rejections based on those applications and granted patents are now withdrawn.
According to MPEP section 804:
“(i) Application under examination has the earlier patent term filing date
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Currently, a provisional nonstatutory double patenting rejection is the only rejection remaining amongst the elected claims (i.e., claims 1, 143, 145, and 146). Note: the instantly elected claims have an earlier effective filing date compared to the co-pending application, 19/489,148. As such, the provisional nonstatutory double patenting rejection is withdrawn such that claims 147 and 149 can be rejoined.
Claims 1, 143, 145, and 146 are allowable. Claims 147 and 149, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among invention I through IV (which is, as set forth in the Office action mailed on September 19, 2026, is hereby withdrawn and claims 147 and 149 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
In summary, claims 147 and 149 are rejoined; claims 1, 143, 145, 146, 147, and 149 are currently pending.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 147 and 149 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Prior art referenced:
Brzezinka et al. (Brzezinka) (Brzezinka, K. et al. Characterization of the Menin-MLL Interaction as Therapeutic Cancer Target. Cancers 2020, 12, 201.; Published: January 14, 2020),
Butler et al. (Butler) (WO2020142557A1; International filing date: December 31, 2019; published July 9, 2020.), and
Furberg (Furberg, C. D. Class Effects and Evidence-Based Medicine. Clin. Cardiol. 2000, 23, pg. IV-15 to IV-19.).
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
Currently, the method claims are broad insofar as they encompass treating:
any autoimmune disease or condition (disclosed in instant claim 147) or
any cancer (disclosed in instant claim 149)
comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of instant claim 145. However, the instant specification does not provide working examples that reasonably represent the full scope of the claimed diseases or explain why the claimed compounds would be expected to treat all the diseases or conditions claimed in instant claims 147 and 149.
Specifically, Example B1 of the instant specification only evaluates the ability of the instant compounds (i.e., inhibitors of Menin/MLL interaction) to inhibit cell proliferation among human MLL-leukemia cells (see para. 00933). The instant specification does not provide any working examples demonstrating the use of the disclosed compounds in treating an autoimmune disease or condition.
Moreover, Brzezinka evaluated a potent and selective menin-MLL interaction inhibitor (i.e., BAY-155) across multiple cancer models both in vitro and in vivo (abstract). Even though Brzezinka found a specific therapeutic activity of BAY-155 primarily in AML/ALL models, in solid tumors, the anti-proliferative effects of BAY-155 were observed in a surprisingly limited fraction of cell line models (and validated in vivo) (abstract). As such, Brzezinka confirmed that “disrupting the menin-MLL complex has a selective therapeutic benefit in MLL-fused leukemia. In solid cancers, effects are restricted to single models and more limited than previously claimed” (abstract, last two sentences). In other words, Brzezinka demonstrates that therapeutic efficacy of a Menin-MLL inhibitor in one cancer type does not necessarily predict efficacy of the same inhibitor in other cancer types.
Therefore, the disclosure of the instant compounds being able to inhibit cell proliferation among human MLL-leukemia cells does not adequately represent the full therapeutic breadth of the claimed therapeutic methods recited in instant claims 147 and 149. Therefore, the specification does not reasonably convey that Applicant was in possession of methods of treating the full scope of cancers and autoimmune disease or condition encompassed by instant claims 147 and 149.
Furthermore, Butler discloses Menin-MLL interaction inhibitors with structures similar to the instant compounds and recites: “In some embodiments, the present invention provides, methods for treating an autoimmune disease or condition comprising administering to a patient in need the pharmaceutical composition of the present invention” (Butler, para. 00315). However, Butler does not provide any working examples that demonstrate the use of the compounds disclosed in Butler in treating an autoimmune disease or condition. Additionally, the prior art itself recognizes that membership in a pharmacological class does not establish that all compounds within that class possess the same therapeutic properties. As explained by Furberg:
“Drugs grouped into a therapeutic class on the basis of a common mechanism of action often have considerably different pharmacodynamic and pharmacokinetic properties” (abstract, 1st sentence);
“Equipotency in terms of clinical efficacy is difficult to determine. Since the concept of “class effect” is a term of convenience that has no universally accepted definition and subsequently should not form the basis for the practice of evidence-based medicine, untested drugs of a “class” should be considered to be unproven drugs” (abstract, last two sentences).
Accordingly, a POSITA would have understood that evidence relating to one or a limited number of compounds being menin-MLL interaction inhibitors does not establish that all compounds within the class of inhibiting menin-MLL interaction possess the same therapeutic utility for any autoimmune diseases or conditions or any cancer.
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.
Note: As discussed above, a provisional nonstatutory double patenting rejection was the only rejection remaining amongst the elected claims (i.e., claims 1, 143, 145, and 146). Since the instantly elected claims have an earlier effective filing date compared to the co-pending application, 19/489,148, the provisional nonstatutory double patenting rejection was withdrawn such that claims 147 and 149 can be rejoined. However, because the claims are not all otherwise in condition for allowance following rejoinder, the provisional nonstatutory double patenting rejection is reinstated against claims 1, 143, 145, and 146 and is also applied to rejoined claims 147 and 149.
Claims 1, 143, 145, 146, 147, and 149 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 8-10, 23, 25, 26, 39, 46, and 67-69 of U.S. Patent Application No. 19/489,148 (‘148).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim sets from the patents and co-pending patent applications listed above as explained below:
Regarding ‘148:
Compound from instant claim 1:
Instant compound encompassed by the following claims disclosed in ‘148:
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(B0700-513)
1, 46
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344
1075
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(B0700-304)
8-10, 26
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1051
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(B0700-341)
23, 25
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316
1041
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(B0700-619)
39
Claims 67 and 68 of ‘148 encompass instant claims 145 and 146.
Claim 69 of ‘148 is directed to a method for treating an autoimmune disease or condition that requires compounds encompassing the ones listed in the table above.
Thus, instant claim 1 represent an obvious variation of the claims of ‘148 (which also encompasses the isotopically-labelled derivatives of the disclosed compounds; see para. 00604 of ‘148) as instant claim 1 is directed to multiple compounds which includes at least one compound that is required to practice claim 69 of ‘148.
Furthermore, claim 69 encompasses instant claim 147.
Overall, the co-pending application claims compounds that overlap with the compounds recited in instant claim 1 (as explained above). The specification of the co-pending application further discloses that “[i]n some embodiments, provided herein is a method for treating a cancer by administering to a subject in need thereof a composition containing a therapeutically effective amount of at least one compound having the structure of Formula (L-I), (L-II), and (I)” (co-pending application, specification, para. 0077; Note: Formula (L-I) is recited in claim 1 of the co-pending application).
Accordingly, a POSITA would have found the subject matter of instant claim 149 (directed to a method for treating a cancer comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of instant claim 145) to have been an obvious variation of the claims of the co-pending application because the co-pending application claims compounds that overlap with the compounds recited in the instant claims while also explicitly identifying cancer as a disease that may be treated in a subject when the subject is administered a compound that is disclosed in the co-pending and the instant application.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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