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 November 7, 2025. Application No. 18/254,897, is a 371 of PCT/JP2021/043654, filed November 29, 2021, and claims foreign priority to Japanese application No. JAPAN 2020-198084, filed November 30, 2020. In a preliminary amendment filed May 30, 2023, Applicant added new claims 12-20. Claims 1-20 are pending.
Species Election
Applicant’s election without traverse of the compound species of formula (3) in the reply filed on November 7, 2025, is acknowledged. Claims 2, 3, and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. The election was made without traverse in the reply filed on November 7, 2025.
Claims 1 and 4-11 are examined below.
Claim Rejections - 35 USC § 112(b)
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.
Claims 7-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 7 and 9 recite the limitation "hydrogen" in the Markush formula definitions for R2, R5 and R6. Claims 7 and 9 depend from claim 1, and in claim 1, R2, R5 and R6 do not include hydrogen. There is insufficient antecedent basis for this limitation in the claim.
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 10 and 11 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for pharmaceutical compositions for treating diseases caused by mitochondrial hyperfission, the specification does not reasonably provide enablement for pharmaceutical compositions for preventing said diseases. 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 pharmaceutical compositions for preventing disease caused by mitochondrial hyperfission. The specification suggests that the claimed compounds exhibit an inhibitory effect on mitochondrial hyperfission through inhibition of dynamin related protein 1 (Drpl)-filamin complex formation. (Specification, p. 1.) There is no evidence or examples presented to suggest that the claimed compounds could prevent any disease. In addition, the prior art fails to provide compensatory guidance. In this case, there is no correlation between the inhibition of mitochondrial hyperfission and preventing any disease which may (or may not) be caused by mitochondrial hyperfission. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
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, 4, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petrow, V., J. of Chem. Soc., 200-3 (1946) (citing the CAS Abstract). The CAS Abstract for Petrow discloses the following compound:
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(Petrow, V., citing the CAS Abstract for the compound depicted above.) This compound reads on a compound of formula (3), wherein formula (3) R1 or R1’are both hydrogen; X is O and R2 is a lower alkyl (ethyl); R3 and R4 are hydrogen; and R5 and R6 are methyl (lower alkyl).
Conclusion
Claims 1, 4, and 6-11 are not allowed.
Claim 5 is 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.
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 on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (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