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 .
Priority
Foreign priority to application JP2022-42288 filed 03/17/2022 is acknowledged. Further, it is acknowledged that the present application is a 371 of international application PCT/JP2023010053 filed 03/15/2023.
Information Disclosure Statement
The information disclosure statements (IDS) filed 09/16/2024, 09/17/2025, and 04/21/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the references included have been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group II (claims 12-22) in the reply filed on 07/27/2026 is acknowledged. The traversal is on the ground(s) that since Groups I and II were examined together in the PCT International Application, there should not be any search or examination burden. This is not found persuasive because the search burden pertains to applications filed under 35 U.S.C. 111(a), whereas the present invention was submitted under 35 U.S.C. 371. See MPEP § 823.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/27/2026.
Claims 12-22 are pending and under current examination.
Specification
The disclosure is objected to because of the following informalities: the tables on pages 15-18 should have figure captions.
Appropriate correction is required.
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.
Claim(s) 12-18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Akao (US 20100092560 A1), in view of Kawachi (WO 2012176842 A1).
Regarding claim 12, 13, and 15, Akao teaches a particulate composition containing reduced coenzyme Q10 in a crystalline state (see claim 4). The composition of Akao comprises ascorbic acids (i.e. antioxidants, see claim 2), and surfactants with HLBs of 10 or less (see claim 20). The composition of Akao is packaged and preserved (i.e. container, para. [0165]). Akao further teaches that the particulate composition is preserved in air where the relative humidity is 60% or less (para. [0110]). The relative humidity disclosed in instant claim 1 overlaps with that of Akao, and as such is obvious. See MPEP § 2144.05(I).
While Akao does not teach specifically the reduced coenzyme Q10 Form II crystal, Kawachi teaches that the crystal polymorphism is found in reduced coenzyme Q10, and that this form (i.e. reduced coenzyme Q10 Form II crystal, see instant specification para. [0006]) is much more stable than the conventional reduced coenzyme Q10 (see abstract).
Akao and Kawachi are considered to be analogous to the claimed invention because they are in the same field of formulations comprising reduced coenzyme Q10. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date, to incorporate the reduced coenzyme Q10 Form II crystal as taught in Kawachi, into the formulation and packaging taught in Akao, for its benefit of being more stable than the conventional reduced coenzyme Q10, as taught in Kawachi above. MPEP § 2143(I)(g).
Regarding claim 14, Akao describes that the formulation comprises polyglycerol esters, sucrose fatty acid esters, and lecithins (see claim 11).
Regarding claim 16 and 17, Akao discloses that the polyglycerol esters and sucrose fatty acid esters (i.e. emulsifiers) make up 0-95 wt.% of the composition, and the coenzyme Q10 makes up 5-100 wt.% of the composition (see claim 10). The ratio of emulsifier to crystal disclosed in instant claim 16, and the percent composition of the emulsifier of instant claim 17, overlap with that disclosed in Akao, and as such they are obvious. MPEP § 2144.05(I)
Regarding claim 18, Akao teaches that the formulation can further comprise a binder (para. [0168]).
Regarding claim 20, as above, Akao teaches that the formulation is a particulate composition (see claim 1).
Regarding claim 21, Akao describes an example of the reduced coenzyme Q10 formulation that is free of a carbonate containing sodium or calcium cations (see comparative example 4, para. [0211]).
Regarding claim 22, Akao describes that the particulate composition is obtained by polydispersing an oily ingredient containing a reduced coenzyme Q10 in a matrix containing a water-soluble ascorbic acid (i.e. water-soluble antioxidant, para. [0015]). The prior art describes a composition utilizing a water-soluble ascorbic acid (i.e. antioxidant) rather than a lipophilic antioxidant. Because the prior art explicitly lacks the lipophilic antioxidant element required by the polydispersed domain structure defined in the negative limitation, the prior art effectively discloses a composition that falls outside that exclusion satisfying the target limitation of claim 22.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Akao (US 20100092560 A1), in view of Kawachi (WO 2012176842 A1), in further view of Ueda (US 20060153911 A1).
While Akao teaches the claimed invention as above, it fails to teach the specific binders of the composition, as stated in instant claim 19.
Regarding claim 19, Ueda teaches a method for preserving reduced coenzyme Q10 in a controlled environment surrounding the capsule to a humidity of less than 60% (see claim 1). The composition has ascorbic acid (i.e. antioxidant) and a polyglycerol fatty acid ester (i.e. emulsifier, see claim 1). Ueda further teaches that composition can comprise a binder such as hydroxypropylmethyl cellulose (para. [0051]).
Akao, Kawachi, and Ueda are considered to be analogous to the claimed invention because they are in the same field of methods of storing reduced coenzyme Q10 crystals to optimize stability. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the binder taught in the composition of Akao with the specific hydroxypropylmethyl cellulose binder disclosed in Ueda, to yield predictable results. Ueda teaches that hydroxypropylmethyl cellulose is effective as a binder in a stable composition of coenzyme Q10. MPEP § 2143(I)(b).
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.
Claim(s) 12-22 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 12-22 of U.S. co-pending Application No. 18/847,330 (hereafter App. ‘330).
Regarding claim 12 of instant invention, App. ‘330 claims a package comprising a solid composition with a reduced coenzyme Q10 form II crystal, an emulsifier having an HLB of 6.0, and an antioxidant (see claim 12). The package has a relative humidity of 50% or more, and there is a container enclosing the solid composition and the gas phase (see claim 12). The relative humidity in the package of instant claim 12 overlaps with that claimed in App. ‘330 claim 12, and as such a case of obviousness exists. MPEP § 2144.05(I).
Regarding claim 13 of instant invention, App. ‘330 claims that the gas phase of the package is air (see claim 13).
Regarding claim 14 of instant invention, App. ‘330 claims that the emulsifier is selected from the group consisting of ester compounds of polyols and fatty acids optionally having substituents wherein the polyols are selected from the group consisting of monoglycerol, polyglycerol, sorbitan, polyoxyethylene sorbitan, sucrose, propylene glycol, polypropylene glycol, ethylene glycol, and polyethylene glycol, and lecithin (see claim 14).
Regarding claim 15 of instant invention, App. ‘330 claims that the antioxidant is selected from a group consisting of ascorbic acid, ascorbic acid salts, erythorbic acid, and erythorbic acid salts (see claim 15)
Regarding claim 16 of instant invention, App. ‘330 claims that the solid composition of the package comprises 1 to 9900 parts by weight of the emulsifier with respect to 100 parts by weight of the crystal (see claim 16).
Regarding claim 17 of instant invention, App. ‘330 claims that the amount of emulsifier in the solid composition is 1-99 wt.% (see claim 17).
Regarding claims 18 and 19 of instant invention, App. ‘330 claims that the solid composition further comprises a binder (see claim 18), and that the binder is one or more selected from the group consisting of hydroxypropyl cellulose and hydroxypropylmethyl cellulose (see claim 19).
Regarding claim 20 of instant invention, App. ‘330 claims a particulate solid composition (see claim 20).
Regarding claim 21 of instant invention, App. ‘330 claims a composition that is free of a carbonate containing a sodium cation and/or calcium cation (see claim 21).
Regarding claim 22 of instant invention, App. ‘330 claims a package where the solid composition is not a composition in which an oily component containing reduced coenzyme Q10 and a lipophilic antioxidant is polydispersed in domain form in a matrix containing a water-soluble excipient (see claim 22).
This is a provisional statutory double patenting rejection because the conflicting claims have not yet been patented.
Conclusion
Claims 12-22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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