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 Claims
Claims 60-83 are pending and under examination.
Priority
This application is a 371 of PCT/US22/81352 12/12/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN- 202141058005, filed on 12/13/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 72-75, and 80-82 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of modulating KAT6A in a subject, comprising administering to the subject in need thereof, select exemplified compounds of formula (I) including compounds 1-65 as disclosed in Table 10 in the specification, as well as a method of treating breast cancer and colon cancer in a subject, comprising administering to the subject in need thereof, select exemplified compounds of formula (I) including compounds 1-65 as disclosed in Table 10 in the specification, does not reasonably provide enablement for a method of modulating KAT6A in a subject comprising administering to the subject in need thereof, the full-scope of compounds of formula (I), or a method of treating the full-scope of diseases claimed to be mediated by KAT6A.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The nature of the invention is complex in that the claims are drawn to a method of modulating KAT6A in a subject, comprising administering to the subject in need thereof, the full-scope of compounds of formula (I), and a method of treating any disease or disorder claimed to be mediated by KAT6A.
However, Applicant only demonstrates that select species of formula (I) are able to inhibit KAT6A, and uses this as a basis to claim treatment using the full-scope of formula(I) in a broad range of diseases that are claimed to be mediated by KAT6A.
Breadth of the Claims: The claims are broad in that the claims recite for a method of modulating KAT6A in a subject comprising administering to the subject in need thereof, the full-scope of compounds of formula (I), and a method of treating the full-scope of diseases claimed to be mediated by KAT6A. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification describes select species of formula (I), including compounds 1-65 as disclosed in Table 10 in the specification, as having inhibitory activity on KAT6A. However, no working examples are given for the full-scope of compounds of formula (I) having inhibitory activity on KAT6A. Further, no working exampled are given for any direct treatment of a disease wherein the compounds of formula (I) are administered to a subject, and no teaching is provided that demonstrates that the full-scope of the claimed diseases are mediated by KAT6A, to an extent that affecting KAT6A alone would be expected to treat the full-scope of the claimed diseases.
While it is noted that the applicant has shown some data for select species of formula (I), including compounds 1-65 as disclosed in Table 10 in the specification, as modulating activity on KAT6A, the applicant is not enabled for modulating KAT6A using the full-scope of compounds of formula (I), or treatment of the full-scope of diseases claimed to be mediated by KAT6A.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. It is known in the art that there is a high degree of specificity between the structure of a compound and its biological activity in a given target. This is supported by Roy, Kunal, and Arkaprava Banerjee. Activity Cliffs. SpringerBriefs in Molecular Science, Cham, Springer Nature Switzerland, 2025. Accessed 12 May. 2026., teaching that even trivial changes in structure can lead to dramatic and unexpected changes in activity, such that it would no longer be feasible to treat a disease primarily mediated by that given activity.
It is not known in the art that the full-scope of claimed diseases to be treated by the compounds are mediated by KAT6A at all, or even to a degree such that merely inhibiting KAT6A would reasonably be expected to treat the full-scope of the diseases. Cancer in particular is known in the art to refer to any one of a large number of distinct diseases, each with distinct mechanisms of growth and resistance, as explained by Conquer Cancer, the ASCO Foundation. Why Haven’t We Conquered Cancer Yet? Understanding the Complexities of Curing Cancer. December 22, 2025, [retrieved on 5/13/2026]. https://www.conquer.org/news/why-havent-we-conquered-cancer-yet-understanding-complexities-curing-cancer (Year: 2016).
Examiner’s decision to enable the Applicant for the treatment of breast cancer and colon cancer specifically is based on the teachings of Roussel-Simonin, C. (Exploring KAT6 as a therapeutic target in breast cancer: epigenetic approaches for
precision medicine), npj breast cancer, Vol. 11, no. 146, pp. 1-10 (Year: 2025) and Huo, J. (Histone acetyltransferase KAT6A contributes to colon cancer malignant progression by inhibiting ferroptosis), BMC Cancer, Vol. 26, no. 150, pp. 1-10 (Year: 2026), both teaching a nexus between KAT6A inhibition and reduction in these cancers, respectively.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is high, as the skilled artisan could not rely on the prior art or instant specification to teach a method of modulating KAT6A in a subject comprising administering to the subject in need thereof, the full-scope of compounds of formula (I), or a method of treating the full-scope of diseases claimed to be mediated by KAT6A.
In order to carry out the claimed invention, one of ordinary skill in the art would have to administer the full-scope of compounds of formula (I) to a subject and determine the effects on KAT6A, as well as determine whether a compound that inhibits KAT6A would be effective in treating the full-scope of diseases claimed by the Applicant to be mediated by KAT6A.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claims 72-75, and 80- 82 are not considered to be fully enabled by the instant specification.
Claims 60-69, and 71-76 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. In claim 60, “A compound of Formula (I)” is not defined in the specification with reasonable clarity as to what entities the applicant is intending to reference.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn to “A compound of Formula (I)”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the ingredients requires more than a mere statement that it is a compound of Formula (I).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984). Accordingly, reciting “A compound of Formula (I)”, in the absence of knowledge as to what constitutes a compound of Formula (I), is not a description. In the instant case, on page 2, paragraph 0008, Applicant discloses “a compound of Formula (I)”. However, other than the mere mention on page 2, paragraph 0008, wherein Applicant simply states “a compound of Formula (I)”, Applicant does not provide any examples of a compound of Formula (I).
There is a selection of species of the claimed genus disclosed that is within the scope of the claimed genus, i.e., Compounds 1-65 on page 43; Table 1 in the specification.
The disclosure of select disclosed species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, the present claims encompass numerous species that are not further described. There is substantial potential for variability among the species.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of what constitutes “a compound of Formula (I)”. The specification does not clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
(Of Note: The following double patenting rejections are PROVISIONAL)
Claims 60-83 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of Co-pending application no. 18/562,758: 1, 4, 5, 7, 8, 15, 21, 22, 23, 24 (for present claims 60-83).
(Of Note: This rejection will support the rejections that follow below where applicable.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compounds and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method. The co-pending claims 1, 4, 5, 7, 8, 15, 21, 22, 23, 24 are all drawn to the same compounds of instant formula (I) and formulations thereof, used in comparable methods of administration to a subject with the same list of the instantly claimed diseases.
Instant formula(I), recited in claim 60, is shown below:
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134
297
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Co-pending formula (I), recited in claim 1, is shown below:
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173
378
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The co-pending teaches the instant formula (I) at least wherein co-pending R1 is hydrogen, co-pending R2 corresponds to the instant R1 taught as alkoxy, co-pending R4 corresponds to the instant Rx taught as hydrogen, co-pending X is a 6 membered cycloalkyl (benzene ring), co-pending Q is a 5 membered heterocycloalkyl ring (furanyl).
The instant claims 60-71, and 77-78 are drawn to the same pharmaceutically acceptable salts, stereoisomers, tautomers, and pharmaceutically acceptable carriers or excipients of the compounds of formula (I) as taught by the co-pending claims 1, 4, 5, 7, 8, and 15, and instant claims 72-76, and 79-83 are drawn to the same methods of using these compounds in modulating KAT6A in a subject, and treating the same list of diseases, as taught by the co-pending claims 21 - 24.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application no.18/562,758. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L 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.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights