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 .
Response to Amendment
The amendments received 03/02/2026 have been entered. Claims 1, 3-5, 7, 9-12, and 14 are pending. Any objection or rejection previously set forth in the Office Action mailed 12/04/2025 not maintained herein has been overcome by Applicant’s amendments and is withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 is directed toward a “coenzyme QH composition”. It is unclear if “coenzyme QH composition” indicates that that composition comprises coenzyme QH in addition to the co-crystal of coenzyme QH and nicotinamide. Moreover, in looking to the specification, examples 6-9 (p. 14-16) demonstrate how the claimed composition is made. While the ratio of coenzyme QH and nicotinamide differs from the claimed co-crystal, the method of making the composition is otherwise the same as the method of making the co-crystal (nicotinamide, coenzyme QH, and ethanol added to a ball mill jar, followed by ball milling for 2 hours and then vacuum drying) and the compositions have substantially similar XRPD and DSC patterns compared to the co-crystal. It is unclear how Applicant differentiates between a co-crystal and a composition if the compositions also have crystalline properties which are the same as the claimed co-crystal. Are the compositions not also co-crystals with a different ratio of coenzyme QH and nicotinamide? How do the compositions differ from the claimed co-crystal if they have the same properties? Clarification is requested. Claim 10 is rejected for depending on claim 7.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prohenz López et al. (WO 2019/162429 A1; IDS filed 12/16/2024) in view of Mei et al. (CN 107721902 A; IDS filed 09/08/2023).
Prohenz López et al. discloses co-crystals comprising ubiquinol (reduced coenzyme Q10) and a hydrogen bond donor with improved stability (p. 2, lines 35-39; p. 3, lines 11-12). Prohenz López et al. additionally teaches a dietary supplement comprising a co-crystal of ubiquinol and a hydrogen bond donor (p. 15, lines 5-12). Prohenz López et al. discloses particular examples of making co-crystals of ubiquinol and a hydrogen bond donor in a 1:1 molar ratio comprising dissolving 3,5-dihydroxybenzoic acid in acetonitrile, ethyl ketone, or diethyl ether, adding ubiquinol until a suspension was observed, and filtering and drying the solid suspension under vacuum (p. 20, lines 24-30; p. 21, Table 8). Prohenz López et al. discloses additional examples wherein the solvent is ethyl acetate or isopropanol (p. 21).
Prohenz López et al. does not disclose a co-crystal of ubiquinol and nicotinamide in a 1:1 stoichiometric ratio. This limitation is obvious over Mei et al.
Mei et al. discloses a co-crystal of apremilast and nicotinamide, wherein the co-crystal has improved physical and chemical properties (English Abstract). Mei et al. discloses the following structure for nicotinamide (p. 5).
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It would be prima facie obvious for one of ordinary skill in the art to try to co-crystallize ubiquinol and nicotinamide. One would have been motivated to do so, with reasonable expectation of success, as nicotinamide is a co-former known in the art to improve stability when co-crystallized with pharmaceuticals. Moreover, nicotinamide would be expected to act as a hydrogen bond donor as desired by Prohenz López et al. via the hydrogens of its amide group. It would additionally be within the ability of one of ordinary skill in the art to arrive at a 1:1 stoichiometric ratio using routine optimization and the teachings of Prohenz López et al.
Examiner additionally notes that while claims 7 and 9-10 require the co-crystal of claim 1, claims 7 and 9-10 are drawn to compositions of matter. Neither the claims nor the specification clearly exclude liquid compositions wherein the co-crystal is dissolved, in which the crystalline form with the XRPD peaks listed in claim 1 would not be maintained. For example, see specification p. 8 which includes combining the co-crystal with diluents.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
In the Remarks filed 03/02/2026, Applicant points to example 6 of the specification to clarify that the coenzyme QH composition also comprises an excess of coenzyme QH or nicotinamide in addition to the co-crystal of claim 1. However, in looking to the specification for further guidance, the specification states on p. 5, “In some embodiments, in addition to the co-crystal… the coenzyme QH composition may comprise an excess amount of nicotinamide, or an excess amount of coenzyme QH…” which suggests that the scope of claim 7 does not require excess coenzyme QH or nicotinamide. The scope of claims 7 and 10 are still unclear. The rejection is maintained.
Allowable Subject Matter
Claims 1, 3-5, 11-12, and 14 are allowed.
Conclusion
Claims 1, 3-5, 11-12, and 14 are allowed. Claims 7 and 9-10 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/M.E.B./Examiner, Art Unit 1624 03/25/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624