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 .
Status of the Claims
Claims 3 and 13 have been canceled.
Claims 1-2, 4-12 and 14-15 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group III, Claims 14-15, and of species mitoquinol, 4F and DMF, in the reply filed on 1/15/2026 is acknowledged. Upon further consideration, species elections are withdrawn.
Claims 1-2 and 4-12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 14-15 are being examined in this application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 14 is directed to a composition comprising (a) one or more mitochondrial targeted antioxidants, and (b) one or more ApoA-I mimetic peptides and/or one or more Nrf2 agonists. Mitochondrial targeted antioxidants include naturally occurring antioxidants such as alpha-lipoic acid, and Nrf2 agonists include naturally occurring compounds such as curcumin. Since claim 14 does not recite specific mitochondrial targeted antioxidants and Nrf2 agonists, naturally occurring mitochondrial targeted antioxidants and Nrf2 agonists read on limitations recited in claim 14, and are “product of nature” exceptions. Therefore, claim 14 is directed to an exception. Claim 14 does not require additional elements. Thus, claim 14 does not amount to significantly more than the law of nature itself. Accordingly, claim 14 is not eligible and should be rejected under 35 U.S.C. § 101.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Dhar et al (US 2017/0367989 A1; 12/28/2017.).
The instant claims recite a composition comprising (a) one or more mitochondrial targeted antioxidants, and (b) one or more ApoA-I mimetic peptides and/or one or more Nrf2 agonists.
Dhar teaches a composition comprising a triphenyl phosophonium (TPP) moiety (one or more mitochondrial targeted antioxidants) (Claim 15) and an L-4F polypeptide (one or more ApoA-I mimetic peptides) (Claims 10-11).
Therefore the reference anticipates the claimed subject matter.
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 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 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 14-15 are rejected 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.).
The instant claims recite a composition comprising (a) one or more mitochondrial targeted antioxidants, and (b) one or more ApoA-I mimetic peptides and/or one or more Nrf2 agonists.
Davis teaches compounds and methods for treating viral infections (Abstract), comprising therapies including mitoquinone (para 0458), and therapies including anti-inflammatory and antioxidant (para 0446).
Davis does not teach said compounds and methods comprise one or more ApoA-I mimetic peptides and/or one or more Nrf2 agonists (claim 14), and the claimed ApoA-I mimetic peptides and Nrf2 agonists (claim 15).
However, Davis does teach said compounds and methods comprise anti-inflammatory and antioxidant (para 0446), wherein said compounds and methods are for treating viral infections including HIV (para 0389).
Lenten teaches apoA-I mimetic peptides such as D-4F are anti-inflammatory agents that may have therapeutic potential (Abstract), and may be exerting their effects at the earliest steps in the sequence of events after viral infection (p.3252 col right – para 1).
In addition, Rosario teaches dimethyl fumarate (DMF), an antioxidant, has been reported to decrease HIV replication (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 combine D-4F (ApoA-I mimetic peptides) and DMF (Nrf2 agonists) with mitoquinone in a composition, since Davis discloses compounds and methods for treating viral infections comprise mitoquinone, anti-inflammatory and antioxidant, Lenten discloses that D-4F is anti-inflammatory and has antiviral activity, and Rosario discloses that DMF is an antioxidant and has antiviral activity. Furthermore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine mitoquinone, D-4F and DMF in a composition for treating viral infections, since each of mitoquinone, D-4F and DMF is known and useful for the same purpose, as evidenced by Davis, Lenten and Rosario, respectively. 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 combine D-4F (ApoA-I mimetic peptides) and DMF (Nrf2 agonists) with mitoquinone in a composition with a reasonable expectation of success.
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 14-15 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, consisting essentially of, or consisting of (a) one or more triphenylphosphonium compounds (TPP Compounds), and (b) one or more bioactive moieties, one or more ApoA-I mimetic peptides, and/or one or more Nrf2 agonists, wherein the one or more TPP Compounds is selected from mitoquinone and salts thereof, mitoquinol and salts thereof, SkQ1, Elamipretide, and Mito-TEMPO, the one or more ApoA-I mimetic peptides is 4F, and the one or more Nrf2 agonists is dimethyl fumarate (DMF).
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759