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 20, 2024. Application No. 18/849,005, is a 371 of PCT/JP2023/013377, flied March 30, 2023, and claims foreign priority to Japanese application No. JAPAN 2022-059884, filed March 31, 2022. Claims 1-12 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 1-3 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Yamazaki et al., U.S. Patent No. 7,183,295. Yamazaki discloses (R)-2-[3-[[N-(benzoxazole-2-yl)-N-3-(4-methoxyphenoxy)propyl]aminomethyl]phenoxy]butyric acid (hereafter pemafibrate) and pharmaceutical compositions thereof. See Yamazaki et al., ‘295 patent, Col. 6., lns. 61-62, for the compound pemafibrate; see also Id., Col 41, lns. 24-49, Example 14, for the same; see Id., Col. 4, lns. 61-64, Col. 30, ln. 64- Col. 32, ln. 61, and Col. 138, lns. 14-16, claim 3, for pharmaceutical compositions of the compounds disclosed therein.
Please take note that the recited use or intended purpose of the claimed pharmaceutical compositions of pemafibrate and the compound pemafibrate itself does not limit claims. See MPEP 2111.02 II, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In this case, the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention as pharmaceutical compositions of pemafibrate and the compound pemafibrate itself. The compound disclosed in the prior art reads on the structural limitation of the claims. Accordingly, prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki et al., U.S. Patent No. 7,183,295, (see the 35 U.S.C. 102(a)(1), Rejection above), in view of Belvisi & Hele, 134 CHEST 152-157 (2008). The claims are drawn to a method of treating a chronic pulmonary disease comprising administering pemafibrate. Yamazaki teaches that pemafibrate is a PPARα agonist useful for treating pathological conditions including inflammation. The difference between the prior art and present invention is the use of the PPAR agonist pemafibrate to treat a chronic pulmonary disease.
Belvisi & Hele teaches that PPARα, like pemafibrate, are useful in treating chronic pulmonary disease. See Belvisi & Hele, Abstract; see also Id., p. 155, 2nd col, 2nd para. thru p. 156, 1st col., 1st para., PPARα; see also Id., p. 156, Conclusion. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious to the ordinary artisan at the time of the invention to use the known PPARα, pemafibrate as taught by Yamazaki to treating a chronic pulmonary disease as taught by Belvisi & Hele. The present invention combines prior art elements according to known methods to yield predictable results.
Claim Rejections - 35 USC § 101 and/or 112(b)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claim 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter, as well as 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. Claim 10-12 are drawn to the “use” of pemafibrate . In this case, the “use” of does not fall within at least one of the four categories of patent eligible subject matter, and fails to recite steps under U.S.C. 101. In addition, claims 10-12 are also rejected under 35 U.S.C. 112(b) as being indefinite for reciting a use without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
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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