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 .
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.
Current Status of 18/880,136
This Office Action is responsive to the amended claims of 30 December 2024.
Claims 6-10 and 21 have been examined on the merits. Claims 6-10 are currently amended. Claim 21 is new.
Priority
The effective filing date is 14 July 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2 January 2026; 6 March 2025; and 30 December 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 6-10 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
NAKAJIMA (Nakajima, A., et. al. “Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), versus placebo in patients with non-alcoholic fatty liver disease.” Aliment Pharmacol. Ther. (2021), 54, 1263-1277, provided by Applicants and referenced in IDS of 30 December 2024).
The prior art NAKAJIMA teaches that (R)-2-[3-[[N-(benzoxazol-2-yl)-N-3-(4- methoxyphenoxy)propyl]aminomethyl]phenoxy]butyric acid (hereinafter referred to as “pemafibrate”) was used in a method to reduce blood LDL-C (blood LDL cholesterol) to a subject in need thereof (see page 1274), thereby anticipating instant claim 6. This also anticipates instant claims 8-9 as high blood LDL-C levels are a tell-tale sign of “hypercholesterolemia”.
Furthermore, NAKAJIMA Table 1 of page 1267 teaches that the subjects receiving pemafibrate were taking concomitant statins, which would have to mean ipso facto that the statins were at least insufficient (else, why else would these patients need to further lower their LDL-C levels?). Thus, this anticipates instant claims 7, 10, and 21.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D 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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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
