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
This is a response to Applicant’s communication filed on September 15, 2024. Application No. 18/847,251, filed September 15, 2024, is a 371 of PCT/KR2023/003562, filed March 17, 2023, and claims foreign priority to Korean applications Nos.: KOREA, REPUBLIC OF 10-2022-0033173, filed March 17, 2022; KOREA, REPUBLIC OF 10-2022-0033174, filed March 17, 2022; and KOREA, REPUBLIC OF 10-2023-0034303, filed March 16, 2023. In a preliminary amendment filed September 15, 2024, Applicant cancelled claims 17-19 and added new 20. Claims 1-16 and 20 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 1-16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morgen et al., Design & Synthesis of Dihydroxamic Acids as HDAC6/8/10 Inhibitors, 15 ChemMedChem 1163-1174 (2020) (cited on the September 15, 2024, Information Disclosure Statement). Morgen discloses Compound 2f (and pharmaceutical compositions thereof) useful for treating a histone deacetylase 6 (HDAC6)-associated disease. See Morgen et al., p. 1164, Fig. 1; see also Id., p. 1166, Scheme 2, as well as Table 1. HDAC8 and HDAC10 inhibitory data. Compound 2f reads a compound of Chemical Formula 1, wherein the formula A is a 4-methoxy substituted phenyl; n is 1; and X is hydrogen (H). Compound 2f of the prior art reads on Compound 51 of claim 5 of the present invention.
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.
Claims 7-16 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating a histone deacetylase 6 (HDAC6)-associated disease, wherein the histone deacetylase 6 (HDAC6)-associated disease is selected from the group consisting of cancer diseases, inflammatory diseases, autoimmune diseases, fibrotic diseases, and degenerative diseases, the specification does not reasonably provide enablement for preventing or ameliorating any disease, as well as treating any HDAC6 associated disease (other than the diseases of claim 11). 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.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to preventing, ameliorating, as well as treating any HDAC6 associated disease. In this case, the specification only provides data to support the HDAC inhibitory activity of compounds of Chemical Formula 1. There is no evidence indicating any disease can be ameliorated or prevented. Furthermore, the specification provides no other direction as to how any disease or condition associated with HDAC6 can be treated other than those known in the art. The prior art fails to provide compensatory guidance on how any disease can be prevented or ameliorated. In this case, there is no correlation between HDAC6 inhibition and treating any associated disease. Similarly, there is no correlation between HDAC6 inhibition and preventing/ameliorating any disease. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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