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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/585,817, 63/558,419, 63/655,961, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated a lack of support for formula I and the variables in claims 1-2, 13-17, 19-25, 28-29 in PRO 63/585,817. Thus claims 1-2, 13-17, 19-25, 28-29 received a priority date of 02/27/2024. A claim by claim analysis indicated a lack of support for formula II and the variables in claims 3-6, 10, 18, 26-27, 30 in PRO 63/585,817 or 63/558,419. Thus claims 3-6, 10, 18, 26-27, 30 received a priority date of 06/04/2024. A claim by claim analysis indicated a lack of support for formula III and the variables in claims 7-9, 31-33 in PRO 63/585,817 or 63/558,419 or 63/655,961. Thus claims 7-9, 31-33 received a priority date of 9/26/2024.
Information Disclosure Statement
The information disclosure statement filed 12/26/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the reference D6 was of such poor resolution it was illegible in places. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement (IDS) submitted on 03/19/2025 is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink (page 1) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 1-33 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. The specification does not recite any methods or examples of compound structures of the instant claims besides derivatives of the formula, but not of the formulas themselves. The specification does not recite the structure necessary to achieve the claimed function. The recitation of only derivatives of the claimed formulas does not lead one skilled in the art to believe that applicant has possession of any and all compounds of the formulas. The claim encompasses a multitude of components with different structures and different mechanisms of action and there is nothing in the prior art to indicate any compound can be used as a suitable alternative for another in the manner claimed.
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 1-33 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.
The term “derivative” in claims 1-33 is a relative term which renders the claim indefinite. The term “derivative” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification only provides examples of derivatives not a definition “As used herein, pharmaceutically acceptable derivatives of a compound include, but are not limited to, salts, esters, enol ethers, enol esters, acetals, ketals, orthoesters, hemiacetals, hemiketals, acids, bases, clathrates, solvates or hydrates thereof” [0023]. Thus one of ordinary skilled in the art would not know what would and what would not be considered a derivative of the instant compounds. For instance how much of the current structure must be conserved to be considered a derivative. For the purposes of examination the broadest reasonable interpretation on derivative is any compound that shares any common chemical groups of the instant compounds.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-33 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by BOZIKIS (BOZIKIS et al., WO 2020254946 A1, 2020-12-24, IDS).
The reference BOZIKIS teaches a derivative(page 91, compound 25) of the instant claimed compounds, wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl.
PNG
media_image1.png
289
549
media_image1.png
Greyscale
This anticipates claims 1-30.
The reference BOZIKIS teaches “26. A pharmaceutical composition comprising a compound of any one of the preceding claims, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent.
27. A method of treating cancer in a patient comprising administering to the patient an amount of a compound of any one of claims 1-25, or a pharmaceutically acceptable salt thereof, that is effective in treating cancer”(reference claims 26-27).
This anticipates claim 31 and 32.
The reference BOZIKIS teaches “TIP60 (KAT5) is the most studied member of the MYST family. TIP60 plays an important role not only in the regulation of transcription but also in the process of DNA damage repair, particularly in DNA double-strand breaks (DSB) (Gil 2017). TIP60 can acetylate p53, ATM and c-Myc. TIP60 and MOF specifically acetylate lysine 120 (K120) of p53 upon DNA damage (Avvakumov 2007). TIP60 has also been implicated in being important for regulatory T-cell (Treg) biology. FOXP3 is the master regulator in the development and function of Tregs and it has been shown that acetylation of FOXP3 by TIP60 is essential for FOXP3 activity (Li 2007, Xiao 2014). Underscoring this, conditional TIP60 deletion in mice leads to a scurfy-like fatal autoimmune disease, mimicking a phenotype seen in FOXP3 knock out mice (Xiao 2014). In cancer, Treg cells can facilitate tumor progression by suppressing adaptive immunity against the tumor….The MOZ locus ranks as the 12th most commonly amplified region across all cancer types (Zack 2013). MOZ is within the 8p11-p12 amplicon, which is seen at frequencies around 10-15% in various cancers, especially breast and ovarian (Turner- Ivey 2014). MOZ was first identified as a fusion partner of the CREB-binding protein (CBP) during examination of a specific chromosomal translocation in acute myeloid leukemia (AML) (Avvakumov 2007; Borrow 1996). MOZ KAT activity is necessary for promoting the expression of MEIS1 and HOXa9, proteins that are typically seen overexpressed in some lymphomas and leukemias. Increased survival of MOZ+/- heterozygote mice in the Em-Myc transgenic model of B-cell lymphoma is seen, where loss of a single MOZ allele leads to a biologically relevant reduction in Meis1 and Hoxa9 levels in pre–B-cells (Sheikh 2015)…In light of the established role of KATs in general, and MYSTs in particular, in diseases such as cancer, a need exists for new inhibitors of these proteins. Summary of the Invention Each of the embodiments of the present invention described below may be combined with one or more other embodiments of the present invention described herein which is not inconsistent with the embodiment(s) with which it is combined. In addition, each of the embodiments below describing the invention envisions within its scope the pharmaceutically acceptable salts of the compounds of the invention” This anticipates claim 33.
Accordingly, the phrase“or a pharmaceutically acceptable salt thereof” is implicit in the description of all compounds described herein. This invention relates to a compound of formula (I)…”(pages 2-5).
Claim(s) 1-32 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Rai (Rai et al., US 2023/0303580 A1, Sep. 28,2023).
The reference Rai teaches a derivative(page 288) of the instant claimed compounds, wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)2R8, R8=OH, b=2, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
PNG
media_image2.png
199
368
media_image2.png
Greyscale
The reference Rai teaches a derivative(page 283) of the instant claimed compounds, wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
PNG
media_image3.png
309
569
media_image3.png
Greyscale
The reference Rai teaches a derivative(page 284) of the instant claimed compounds, wherein Z6-Z4=CH, R4=H, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
PNG
media_image4.png
309
569
media_image4.png
Greyscale
The reference Rai teaches a derivative(page 86) of the instant claimed compounds, wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkoxy, R6=H.
PNG
media_image5.png
260
621
media_image5.png
Greyscale
This anticipates claims 1-30.
The reference Rai teaches “A pharmaceutical composition comprising a compound of any one of claims 1- 93 or a stereoisomer, a mixture of stereoisomers, and/or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable carrier”( reference claim 94) and “95 . A method of treating a condition, disease, or disorder by inhibiting a MYST family lysine acetyl transferase, including KAT6A and KAT6B, comprising administering to a patient in need thereof a therapeutically effective amount of the compound of any one of claims 1- 93 or a stereoisomer, a mixture of stereoisomers, and/or a pharmaceutically acceptable salt thereof or a therapeutically effective amount of the composition of claim 94 to a subject in need thereof. 96 . The method of claim 95, wherein the condition, disease, or disorder is a hyperproliferative disorder or cancer” (reference claims 94-96).
This anticipates claims 31-32.
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 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-55 of U.S. Patent No. 12187732 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent ‘732 claims:
PNG
media_image6.png
170
413
media_image6.png
Greyscale
PNG
media_image7.png
386
452
media_image7.png
Greyscale
PNG
media_image8.png
150
386
media_image8.png
Greyscale
wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
This anticipates claims 1-30.
PNG
media_image9.png
60
272
media_image9.png
Greyscale
This anticipates claim 31.
The specification teaches “Provided herein are compounds of Formula (I). Methods for the preparation of the compounds of Formula (I) and intermediates useful in the preparation of the compounds of Formula (I) are described herein. The compounds of Formula (I) may be useful as inhibitors of the MYST family of lysine acetyltransferases (KATs) for the treatment of and/or prophylaxis of hyperproliferative diseases, disorders or conditions such as cancer. In particular, the compounds of Formula (I) are useful for the inhibition of KAT6A and KAT6B which are enzymes frequently mutated, overexpressed, amplified and/or translocated in cancer, altering their normal expression, activity and function. The use of the compounds of Formula (I) in the manufacture of pharmaceutical compositions or for treating cancers is further described, including for treating cancer in combination with other anti-cancer agents”[column 1]. A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
This anticipates claim 32.
Claims 1-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11976075 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Patent ‘075 claims:
PNG
media_image10.png
332
629
media_image10.png
Greyscale
wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=O, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
This anticipates claims 1-31.
The patent ‘075 teaches “Provided herein are compounds of Formula (I). Methods for the preparation of the compounds of Formula (I) and intermediates useful in the preparation of the compounds of Formula (I) are described herein. The compounds of Formula (I) may be useful as inhibitors of the MYST family of lysine acetyltransferases (KATs) for the treatment of and/or prophylaxis of hyperproliferative diseases, disorders or conditions such as cancer. In particular, the compounds of Formula (I) are useful for the inhibition of KAT6A and KAT6B which are enzymes frequently mutated, overexpressed, amplified and/or translocated in cancer, altering their normal expression, activity and function. The use of the compounds of Formula (I) in the manufacture of pharmaceutical compositions or for treating cancers is further described, including for treating cancer in combination with other anti-cancer agents”(column 1). A compound claim can be used to reject a method claim if the utility is disclosed in the specification. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010). See also MPEP § 804(II)(B)(2)(a).
This anticipates claim 32.
Claims 1-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-97 of copending Application No. 18/917,615 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because :
The application claims:
PNG
media_image11.png
463
662
media_image11.png
Greyscale
wherein Z6-Z4=CH, R4=methoxy, R3=-O(CH2)R8, R8=H, b=1, Z1=N, Z3=Z2=C, R2=alkyl, R1=H, X= CH2, Het= 5- membered heteraryl, a= 1, R7=C(O)R17, R17= alkynyl, R6=H.
This anticipates claims 1-30.
PNG
media_image12.png
232
642
media_image12.png
Greyscale
This anticipates claims 31-32.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-33 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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, Kortney Klinkel can be reached at (571) 270-5239. 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.
/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights