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 August 10, 2023. Application No. 18/276,762, is a 371 of PCT/JP2022/005738, filed February 14, 2022, and claims foreign priority to Japanese patent application No. JAPAN 2021-021815, filed February 15, 2021. In a preliminary amendment filed August 10, 2023, Applicant added new claims 11 and 12. Claims 1-12 are pending.
Claim Rejections - 35 USC § 101
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.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 1-12 are drawn to orotic acid and compositions thereof. Orotic acid is a natural product. In this case, there is no indication that orotic acid has any characteristics (structural, functional, or otherwise) that are different from the non-isolated orotic acid. Because there is no difference between the claimed compound and the naturally occurring compound, the claimed compound does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. According the claim is directed to an exception. Because the claim does not include any additional features that could add significantly more to the exception, the claims do not qualify as eligible subject matter, and is reject accordingly.
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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furukawa, WO2020/218148 A1 (cited on the September 26, 2023, IDS). Furukawa discloses an agent and a food composition for body temperature lowering (a body temperature elevation suppressor) comprising orotic acid as the active ingredient in its free form or as a salt. See Furukawa, WO ‘148, para. [0001]; see Id., para. [0018], for orotic acid in the free state or salt form; see Id., claims 6 and 7, for body temperature is the core body temperature.
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 1-12 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a body temperature lowering (body temperature elevation suppressor) agent or food composition comprising orotic acid (uracil-6-carboxylic acid), the specification does not reasonably provide enablement for the use of an orotic acid derivative. 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 of the present invention are broadly drawn to an agent and food composition for lowering body temperature comprising orotic acid as well as it is derivatives. However, the specification teaches only the use of orotic acid and not the use of its derivatives. (Specification, Fig. 1-8.) In addition, the prior art fails to provide compensatory guidance. In this case, there is no correlation between using an orotic acid derivative as an agent or in a food composition for lowering temperature (body temperature elevation suppressor). 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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