DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of the species of myelofibrosis and fluconazole in the reply filed on April 24, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species was anticipated by the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration.
4. Claims 31-33 and 37-38 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on April 24, 2026.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on January 8, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
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.
6. Claim 4 recites the limitation "the dihydrochloride monohydrate.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 from which this claim depends on does not recite a dihydrochloride monohydrate.
Claim Rejections - 35 USC § 102
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.
7. Claim(s) 1-18, 22-30 and 34-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020068755. The reference has a publication date of April 2, 2020 which antedates the present claims having an effective filing date of December 15, 2021 and priority claim to provisional application dated December 16, 2020.
The reference teaches methods of treating myeloproliferative disorders including myelofibrosis, primary myelofibrosis, high risk primary myelofibrosis, secondary myelofibrosis, post-essential thrombocythemia myelofibrosis, post-polycythemia vera myelofibrosis, etc. by administration of a compound of formula I and fluconazole (a CYP3A4 inhibitor). See paragraphs [0008], [0021], [0103]. Present claims 1-4, 22-30. The method comprises administration of pharmaceutically acceptable salts such as dihydrochloride monohydrate – paragraph [0008]. The reference teaches various dosages and modes of administration as recited in present claims 5-17. See paragraphs [0063]-[0065]. The reference teaches further administering thiamine or thiamine equivalent as recited in claims 34-36 and monitoring thiamine levels. See paragraphs [0009], [0015], [0017]. The reference teaches monitoring cognitive assessment according to present claim 18. See paragraph [0022].
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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