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 .
Election/Restrictions
Applicant's election with traverse of claims 4-6, and the species reduced coenzyme Q10 Form I crystal, in the reply filed on 6/15/2026 is acknowledged. The traversal is on the ground(s) that there are overlapping technical features between the groups of claims and there would be no undue burden to examine all claims and species.
In view of the prior art search, the restriction requirement between Group I and Group II is withdrawn; and the species election requirement is withdrawn.
Regarding the restriction between Groups I and III and between Groups II and III, the arguments are not found persuasive because the overlapping features between the groups of inventions are not special technical features, as set forth in the restriction requirement, and therefore unity of invention is lacking. Further, regarding the argument that there is no undue burden, this is not found persuasive because the instant application is a national stage application submitted under 35 U.S.C. 371, and therefore requires unity of invention analysis rather than the independent and distinct analysis required for applications filed under 35 U.S.C. 111(a). Applicant is directed to MPEP § 823. The unity of invention analysis does not require establishment of undue burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/15/2026.
Priority
This application is a 371 of PCT/JP2022/047012 (12/21/2022) which claims priority to JP2021-210678 (12/24/2021) and JP2022-152299 (9/26/2022).
The certified copies of the foreign priority documents are not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 6/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kitanaka et al., US 2016/0089332 A1.
Regarding claims 1 and 4, Kitanaka teaches a gel-like composition in which ubiquinol (reduced coenzyme Q10) is dispersed and stabilized in a gel (Kitanaka Abstract). The composition comprises ubiquinol and water (p. 2 para. 33). The ubiquinol used in the composition is a solid substance (p. 3 para. 41). Kitanaka teaches storing the composition over long periods of time (p. 2 para. 31; p. 10 para. 150). Thus, Kitanaka teaches a method of storing reduced coenzyme Q10, comprising storing a composition comprising solid reduced coenzyme Q10 and water.
Regarding the limitation in claim 4 “for controlling oxidation of reduced coenzyme Q10”, Kitanaka teaches a composition comprising 2% by weight ubiquinol and 16% by weight water, formulated as a gummy candy (p. 12 para. 176). Kitanaka teaches that the composition comprising ubiquinol and water is stored, and oxidation of ubiquinol is prevented (p. 12 para. 180). Thus, Kitanka teaches a method for controlling oxidation of reduced coenzyme Q10 comprising storing a composition comprising solid reduced coenzyme Q10 and water.
Regarding claims 2 and 5, Kitanaka teaches that the solid ubiquinol powder in the composition is not crystallized, i.e. is an amorphous solid of reduced coenzyme Q10 (p. 10 para. 154).
Regarding claims 3 and 6, regarding a solid composition comprising solid QH wetted with water, the instant specification states that such a solid composition is not limited in the content of water and is preferably 0.05 parts by mass or more and more preferably 0.10 parts by mass or more based on 1 part by mass of solid QH, and the solid composition can further contain other components, in addition to water and QH (see instant specification p. 8 para. 33). Kitanaka teaches a composition comprising 2% by weight ubiquinol and 16% by weight water, formulated as a gummy candy (p. 12 para. 176). Thus, the composition of Kitanaka is considered to be a solid composition which comprises solid QH wetted with water, as set forth in the instant specification.
Regarding claim 10, Kitanaka teaches that the solid reduced coenzyme Q10 is not pre-formulated with clathrate forming material or a water-soluble excipient, is not coated with a coating material, and is not present in a capsule. Kitanaka teaches that the ubiquinol used in the compositions is a purified ubiquinol powder, and is not pre-formulated (p. 3 para. 43; p. 10 para. 154).
Regarding claims 11 and 12, Kitanaka teaches that the average particle size of ubiquinol is 11 µm (p. 12 para. 178).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/722,968 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to methods of storing reduced coenzyme Q10.
Regarding instant claims 1 and 4, claim 1 of ‘968 recites a method for storing reduced coenzyme Q10, comprising storing a composition comprising reduced coenzyme Q10, said composition having a water activity at 25°C of 0.50 or more. Claim 6 of ‘968 recites a method for controlling oxidation of reduced coenzyme Q10 comprising storing a composition comprising reduced coenzyme Q10, said composition having a water activity at 25°C of 0.50 or more.
Regarding instant claims 2-3, 5-6, and 10, the limitations of these dependent claims are recited in claims 1-15 of ‘968.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of copending Application No. 18/722,968 in view of Kitanaka et al., US 2016/0089332 A1.
The teachings of ‘968 regarding instant claim 1 are set forth above. The claims of ‘968 do not recite that the solid reduced coenzyme Q10 has an average particle size of 1 μm or more (claims 11 and 12).
Regarding instant claims 11 and 12, Kitanaka teaches a method of storing reduced coenzyme Q10, comprising storing a composition comprising solid reduced coenzyme Q10 and water (p. 2 para. 33). Kitanaka teaches that the average particle size of ubiquinol is 11 µm (p. 12 para. 178).
It would have been obvious for a skilled artisan to combine ‘968 with the teachings of Kitanaka, arriving at a method comprising storing a composition comprising solid reduced coenzyme Q10 and water wherein the average particle size of ubiquinol is 11 µm. Both ‘968 and Kitanaka are directed to methods of storing coenzyme Q10 with water. It would have been obvious that a composition as recited in ‘968 could be comprised of ubiquinol with a particle size as instantly claimed, as Kitanaka teaches a composition with ubiquinol and water wherein ubiquinol has a particle size of 1 µm or greater.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, and 14 of copending Application No. 18/722,374 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to methods of storing reduced coenzyme Q10.
Regarding instant claims 1 and 4, claim 1 of ‘374 recites a method for storing reduced coenzyme Q10, comprising storing a composition comprising reduced coenzyme Q10, said composition having a water activity at 25°C of 0.45 or less. Claim 4 of ‘374 recites a method for controlling oxidation of reduced coenzyme Q10 comprising storing a composition comprising reduced coenzyme Q10, said composition having a water activity at 25°C of 0.45 or less.
Regarding instant claim 10, the limitations of this dependent claim are recited in claims 10 and 14 of ‘374.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-3, 5-6, and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 4, 10, and 14 of copending Application No. 18/722,374 in view of Kitanaka et al., US 2016/0089332 A1.
The teachings of ‘374 regarding instant claim 1 are set forth above. The claims of ‘374 do not recite that the solid reduced coenzyme Q10 in a form as recited in claims 2-3 or 5-6, or that has an average particle size of 1 μm or more (claims 11 and 12).
Regarding claims 2-3 and 5-6, Kitanaka teaches a method of storing reduced coenzyme Q10, comprising storing a composition comprising solid reduced coenzyme Q10 and water (p. 2 para. 33). Kitanaka teaches that the solid ubiquinol powder in the composition is not crystallized, i.e. is an amorphous solid of reduced coenzyme Q10 (p. 10 para. 154). Kitanaka teaches a composition comprising 2% by weight ubiquinol and 16% by weight water, formulated as a gummy candy (p. 12 para. 176). Thus, the composition of Kitanaka is considered to be a solid composition which comprises solid QH wetted with water, as set forth in the instant specification.
Regarding instant claims 11 and 12, the teachings of Kitanaka are set forth above.
It would have been obvious for a skilled artisan to combine ‘374 with the teachings of Kitanaka, arriving at a method of storing reduced coenzyme Q10, comprising storing a composition comprising solid reduced coenzyme Q10 and water, wherein the ubiquinol is an amorphous solid and the composition is a solid composition, wherein the average particle size of ubiquinol is 11 µm. Both ‘374 and Kitanaka are directed to methods of storing reduced coenzyme Q10 with water. It would have been obvious that a composition as recited in ‘374 could be comprised of ubiquinol that is an amorphous solid form with a particle size as instantly claimed, as Kitanaka teaches a composition with ubiquinol as an amorphous solid and water wherein ubiquinol has a particle size of 1 µm or greater. It would further be obvious based on the teachings of Kitanaka that a composition in the method of ‘374 could be formulated as a solid composition comprising the solid reduced coenzyme Q10 wetted with water.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-6 and 10-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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