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 July 23, 2026. 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. In an amendment filed July 23, 2026, Applicant cancelled claims 1-6 and 9-12, and added new claims 13-16. Claims 7, 8, and 13-16 are pending.
Rejections Withdrawn
The rejection of claims 7 and 8 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter, is withdrawn in view of Applicant’s July 23, 2026, Amendment & Remarks.
The rejection of claims 7 and 8 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acid), the specification does not reasonably provide enablement for the use of an orotic acid derivative, is withdrawn in view of Applicant’s July 23, 2026, Amendment & Remarks..
Rejections Maintained
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.
The rejection of claims 7 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Furukawa, WO2020/218148 A1 (cited on the September 26, 2023, IDS), is maintained for reasons made of record. Applicant argues the Furukawa does not disclose the foodstuffs limitation of newly amended claims 7 and 8; and further argues that the prior art fails to disclose the lowering body core temperature limitation. Applicant’s arguments have been fully considered and are not persuasive.
First, Applicant argues that Furukawa does not disclose the foodstuffs limitation of the amended claims. However, Furukawa specifically discloses compositions including foodstuffs compositions as presently claimed. See Furukawa et al., WO ‘148, para. [0024]. It is inherent in the term foodstuffs, as disclosed in the prior art, to include those specific foodstuffs of the amended claims. See Furukawa et al., US2022/0016114 A1, para. [0062]-[0068]; see Id., specifically, para. [0063], for common foodstuffs including those of the amended claims.
With respect to the lowering body core temperature limitation, the recited use or intended purpose of the claimed composition does not constitute a limitation of the claims when the claims are clearly drawn to a composition. 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, a food composition comprising orotic acid or salt thereof. Accordingly, as presently construed prior art anticipates the claimed invention.
As stated in the April 23, 2026, Non-Final Office action, Furukawa discloses a food composition 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.
Conclusion
Claims 7 and 8 are not allowed.
Claims 13-16 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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