DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 9/11/2026 have been received and entered into the case. Claims 3 and 13 have been canceled, Claims 16-18 have been added. Claims 1-2, 4-12 and 14-18 are pending, Claims 1-2 and 4-12 have been withdrawn, and Claims 14-18 have been considered on the merits. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claim 14 under 35 U.S.C. 101 are withdrawn in view of applicant’s amendments.
Rejections of Claim 14 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Dhar et al (US 2017/0367989 A1; 12/28/2017.) are withdrawn in view of applicant’s amendments.
Rejections of Claims 14-15 under 35 U.S.C. 103 as being unpatentable over Davis et al (US 2013/0171103 A1; 7/4/2013. Cited on IDS) in view of Lenten et al (Circulation. 2004;110:3252-3258.) and Rosario et al (J Neuroimmune Pharmacol. 2018;13(3):345-354.) are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 112
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 14-18 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 pre-AIA the applicant regards as the invention.
Claim 14 recites “(10-(4,5-dimethoxy-2-methyl-3,6-dioxo-1,4- cyclohexadienyl) decyl triphenylphosphonium)” (line 2-3) and “(10-(4,5-dimethoxy-2-methyl-3,6- dihydroxy-1,4-cyclohexadienyl) decyl triphenylphosphonium” (line 3-4). It is unclear what the parenthetical information is conveying. Further, parenthesis are reserved for reference characters and information within parenthesis has no effect on the scope of the claims. See MPEP 608.01(m).
Claim Rejections - 35 USC § 102
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 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 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 14 and 16 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Savel et al (US 2018/0000950 A1; 1/4/2018.).
The instant claims recite a composition comprising (a) one or more mitochondrial targeted antioxidants selected from mitoquinone (10-(4,5-dimethoxy-2-methyl-3,6-dioxo-1,4- cyclohexadienyl) decyl triphenylphosphonium), mitoquinol (10-(4,5-dimethoxy-2-methyl-3,6- dihydroxy-1,4-cyclohexadienyl) decyl triphenylphosphonium), and salts thereof, and (b) one or more ApoA-I mimetic peptides and/or one or more Nrf2 agonists.
Savel teaches a composition comprising antioxidants (para 0500), wherein said antioxidants comprise mitoquinone mesylate (para 0503), resveratrol, alpha lipoic acid, lycopene, and lutein (one or more Nrf2 agonists) (para 0501).
Therefore the reference anticipates the claimed subject matter.
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 of this title, 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.
Claims 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Savel et al (US 2018/0000950 A1; 1/4/2018.) as applied to claims 14 and 16 above, further in view of Lenten et al (Circulation. 2004;110:3252-3258.), McGuire et al (Scientific Reports. 2016;6:31159.) and Li et al (Experimental Neurology. 2013;250:239-249.).
Savel does not teach the composition comprises one or more ApoA-I mimetic peptides as claimed (claim 15), dimethyl fumarate (DMF) (claim 17) and sulforaphane (claim 18).
However, Savel does teach the composition comprises antioxidants, and an anti-inflammatory composition can be incorporated (para 0930). Before the effective filing date of the claimed invention, it was well-known in the art that apoA-I mimetic peptides such as D-4F, dimethyl fumarate (DMF) and sulforaphane possess antioxidant and/or anti-inflammatory activities. In support, Lenten teaches apoA-I mimetic peptides such as D-4F are anti-inflammatory agents that may have therapeutic potential (Abstract). In addition, McGuire teaches dimethyl fumarate (DMF) possesses anti-inflammatory properties (Abstract). Finally, Li teaches sulforaphane has potent antioxidant and anti-inflammatory activities (Abstract).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate D-4F (ApoA-I mimetic peptides), DMF and sulforaphane, since Savel discloses a composition comprises antioxidant and anti-inflammatory agents, Lenten discloses that D-4F is an anti-inflammatory agent, McGuire discloses that DMF possesses anti-inflammatory properties, and Li discloses that sulforaphane has potent antioxidant and anti-inflammatory activities. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to incorporate D-4F, DMF and sulforaphane with a reasonable expectation for successfully obtaining a composition.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 14-18 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 14-15 and 22-24 of co-pending Application No. 17/570,737 (referred to as the ‘737 application).
Claims 14-15 and 22-24 of the ‘737 application recite a composition comprising a mixture of one or more bioactive moieties, one or more ApoA-I mimetic peptides, and/or one or more Nrf2 agonists, wherein the one or more ApoA-I mimetic peptides is 4F, the one or more Nrf2 agonists include sulforaphane and dimethyl fumarate (DMF). The composition comprises mitoquinol mesylate.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that Davis, Lenten, and Rosario, alone or in combination, fail to teach or suggest a composition that comprises both (1) mitoquinol or mitoquinone, or a salt thereof, and (2) an ApoA-I mimetic peptide or an Nrf2 agonist. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims 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 extension fee 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 LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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, Curtis Mayes can be reached on (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lynn Y Fan/
Primary Examiner, Art Unit 1759
