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 .
DETAILED ACTION
Status of the Claims
Newly submitted claims 73-86 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h).
In the instant case, the process as claimed (a method of treating leukemia) can be practiced with another materially different product. For example, other chemotherapeutic agents, immunotherapies, or T-cell therapies could be administered in the treatment of the same condition.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 73-86 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 2, 48, and 69-86 are pending. Claims 73-86 are withdrawn from further consideration as being directed towards nonelected inventions. Claims 2, 48, and 69-72 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on June 22nd 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 103 Rejections Overcome by Unexpected Results
Applicant’s amendments and arguments in the response filed on June 22nd 2026 are acknowledged. Applicant amends the claims to be directed only towards the treatment of leukemia in particular and not cancer generally, thus significantly limiting the scope of the claims. Applicant further argues that the instant claims are allowable over Cacatian (U.S. Patent No. 11,479,557) because Cacatian’s compounds, and especially Cacatian’s preferred compound (Example 252),
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(herein referred to as Revumenib)
are known to, in addition to inhibiting the menin protein, have the off-target effect of inhibiting the ether-a-go-go related gene (hERG), a known regulator of the kv11.1 potassium channel. Thus, while Revumenib has received FDA approval for the treatment of particular forms of leukemia, it has done so with a warning of prolonged QTc interval, noting a risk of life-threatening arrhythmia (see the FDA label attached on the application file as Exhibit A).
In contrast, applicant’s compounds have demonstrated low hERG inhibition, thus decreasing this risk while sustaining menin-inhibiting properties. As one of ordinary skill in the art could not have reasonably predicted the decrease in hERG inhibitory activity from the prior art, applicant’s compounds are nonobvious over Cacatian for the reasons of unexpected results.
Nonstatutory Double Patenting Rejections Overcome by Unexpected Results
The nonstatutory double patenting rejections over U.S. Patent No. 11,479,557, co-pending Application No. 19/180,560, co-pending Application No. 18/863,966, co-pending Application No. 17/917,193 (now U.S. Patent No. 12,564,590), and co-pending Application No. 19/458,303 were made for the same reasons as the above 103 rejections and are thereby withdrawn on the grounds of unexpected results (as stated above).
Nonstatutory Double Patenting Rejections Maintained
Applicant states in the response filed on June 22nd 2026 that if the rejection of claims 2 and 48 on the grounds of obviousness-type double patenting over claims 1-26 of U.S. Patent No. 11,919,901 is maintained and the claims are otherwise deemed allowable, Applicant will file a terminal disclaimer as needed.” As such, the nonstatutory double patenting rejections over claims 1-26 of U.S. Patent No. 11,919,901 are maintained.
Examiner further notes that:
The newly added claims 69-72 incorporate limitations of the previously rejected canceled claims and are thus rejected below for the same reasons.
The nonstatutory double patenting rejection of claims 2, 48, and 69-72 is the only remaining rejection.
Nonstatutory Double Patenting Rejections Reiterated
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.
The instant claims are directed towards a method of treating cancers, including hematological cancers, via administration of a compound of Formula (0):
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.
Claims 1-3, 5, 7, 10, 16-19, 27, 30-33, 42, 44, 46, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,919,901. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches the treatment of leukemia (a hematological cancer) via administration of equivalent compounds to those of the instant application.
Conclusion
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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 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, Jeffrey 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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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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