Detailed Action
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 of the Claims
Claims 1-5, 16, 18, 25-27, 32, 37-41, 43, 45-46, 50-53, and 76-78 are pending. Claim 1-5, 16, 18, 25-27, 32, 37-41, 43, 45-46, 50-53, and 78 are rejected. Claims 76 and 77 are objected to.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 4/26/2024 and 11/25/2025 have been considered by the Examiner.
Claim Objections
Claim 51 is objected to because of the following informalities: End of line 2 should read “capsule and tablet”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 46 is 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 46 renders unclear whether “an acid-reducing agent” may or may not be concomitantly administered with the regimen of instant claim 1. The language is confusing and is consequently indefinite. Examiner recommends clarifying the language to be precise about the inclusion or exclusion of an acid-reducing agent.
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.
( 1 of 2) Claims 1, 37-41, 43, 45-46, 50-53, and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12486262. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1 and providing
PNG
media_image1.png
153
330
media_image1.png
Greyscale
to a subject in need thereof, US12486262 teaches administering an identical compound to a subject in need thereof, also.
Specifically, regarding the following exclusion limitation of the instant claims and specifically claims 37-41, 43, and 45-46 (claim 46 has been rejected under 112b supra):
PNG
media_image2.png
93
649
media_image2.png
Greyscale
, US12383555 does not claim the inclusion of such items (is silent to them). It would have been obvious to a PHOSITA, from the claims of US12383555, to not include such treatment items.
Regarding instant claims 50-51, 53, and 78 the specification of US12383555 allows for the claimed administration of the compound to be in a pharmaceutical composition, orally, and capsule form (see column 13, lines 43-57).
Regarding instant claim 52 with specific stereochemistry, “An optically active isomer is unpatentable over a prior art racemate or optical isomer of opposite rotation in the absence of unexpected or unobvious beneficial properties”. In re Adamson et al. (CCPA) 1960 275 F2d 952, 125 USPQ 233.
(2 of 2) Claims 1-5, 16, 18, 25-27, 32, 37-41, 43, 45-46, 50-53, and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12383555. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-5, 16, 18, and 25, US12383555 teaches “treating acute myeloid leukemia” with the following compound:
PNG
media_image3.png
127
316
media_image3.png
Greyscale
(see claims 1 and 13). Acute myeloid leukemia is a form of (metastatic) cancer, which is embraced by the instant claims. Regarding instant claim 26, the instant specification does not provide a definition for “advanced” wherein the leukemia of US12383555 may be advanced.
Specifically, regarding the following exclusion limitation of the instant claims and specifically claims 37-41, 43, and 45-46 (claim 46 has been rejected under 112b supra):
PNG
media_image2.png
93
649
media_image2.png
Greyscale
, US12383555 does not claim the inclusion of such items (is silent to them). It would have been obvious to a PHOSITA, from the claims of US12383555, to not include such treatment items.
Regarding instant claim 27, US12383555 claim 9 recites the following:
PNG
media_image4.png
65
321
media_image4.png
Greyscale
.
Regarding instant claim 32, US12383555 claim 3 recites the following:
PNG
media_image5.png
33
321
media_image5.png
Greyscale
.
Regarding instant claims 50-51, 53, and 78 the specification of US12383555 allows for the claimed administration of the compound to be in a pharmaceutical composition, orally, and capsule form (see column 40, lines 39-51).
Regarding instant claim 52 with specific stereochemistry, “An optically active isomer is unpatentable over a prior art racemate or optical isomer of opposite rotation in the absence of unexpected or unobvious beneficial properties”. In re Adamson et al. (CCPA) 1960 275 F2d 952, 125 USPQ 233.
Allowable Subject Matter
Claims 76 and 77 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art to the instant claims is WO2019152437. WO2019152437 teaches the following compound as a BRG1/BRM inhibitor (arrows added):
PNG
media_image6.png
99
252
media_image6.png
Greyscale
, which differs from the instant compound of formula (I) in multiple locations, including those of the added arrows. Therefore, the prior art does not provide motivation for, nor render obvious the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626