DETAILED ACTION
This office action is in response to the Applicant’s filing dated July 13th, 2026.
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 .
Status of Claims
Claims 1-3, 5-9 and 11 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on July 13th, 2026. Acknowledgement is made of the amendment of claims 1, 5 and 11; and cancelation of claims 4, 10 and 12-17.
Claims 3 and 5-6 remain withdrawn. Claims 1-2, 7-9 and 11 will be examined herein.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections
Necessitated by Claim Amendment
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 1-2 and 7-9 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.
The term “severe” in claim 1 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the distinction between an infection and a severe infection is unclear, and the metes and bounds of the claim have been rendered unclear. In the interest of compact prosecution, the Examiner will include all degrees of infection for prior art purposes.
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 (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 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.
Claims 1-2, 7-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skulachev et al (WO 2012/167236 A2), cited in a previous Office action.
Regarding claim 1-2, 7 and 9, Skulachev teaches a method of treating an inflammatory disorder including septic shock in a patient comprising administering to the patient a therapeutically effective amount of a mitochondrially targeted antioxidant (page 2, paragraph [0004]; page 4, paragraph [0013]); wherein the antioxidant compound is SkQ1H2 (page 4, paragraph [0012]) which is the reduced form of SkQ1 (pages 13-14, paragraph [0044]); administered via injection (page 4, paragraph [0015]); further comprising ascorbic acid which is an additional therapeutic agent (page 4, paragraph [0017]).
Moreover, Skulachev expressly teaches treatment of induced septic shock in male BALB/c mice with the pharmaceutical form of SkQ1, which is its reduced form SkQH2 (page 13, paragraph [0013]), in water administered parenterally (page 22, paragraphs [0074-0075]). Skulachev expressly discloses that SkQ1 acts as an anti-inflammatory agent that has a therapeutic application for septic shock treatment (page 23, paragraph [0077]).
Regarding claim 8, Skulachev teaches the method as described in the above rejection, preventing deconstruction of cell-to-cell contacts between endothelial cells of the subject is the consequence after administering the effective amount of the SkQ compound, including SkQ1H2.
MPEP § 2112 (I) states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding claim 11, Skulachev teaches a stable, liquid MTA-based pharmaceutical composition applicable in clinical practice, and is thus equivalent to a kit or a package seen in clinical practice (page 6, paragraph [0032]; page 11, paragraph [0036]).
Thus, the teachings of Skulachev anticipate the method and kit of instant claims 1-2, 7-9 and 11.
Maintained Objections and/or Rejections
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 (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 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.
Claims 1-2 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skulachev et al (WO 2014/116591 A2), cited in a previous Office action.
Regarding claim 1-2, Skulachev teaches a method of treating an inflammatory disorder in a patient comprising administering to the patient a therapeutically effective amount of a mitochondrially targeted antioxidant (pages 5-7, paragraph [0012]; page 42, claim 11); wherein the antioxidant compound is SkQ1H2 (page 7, paragraph [0013]; page 43, claim 12) which is the reduced form of SkQ1 (pages 14-15, paragraph [0067]); wherein the inflammatory disorder is caused by infection (page 7, paragraph [0014]; page 43, claim 13).
Regarding claim 8, Skulachev teaches a method of preventing the disassembly of endothelial cell-to-cell contact in a mammal comprising administering a therapeutically effective amount of a mitochondrially targeted antioxidant (pages 7-8, paragraphs [0015]; page 44-45, claim 18); wherein the antioxidant compound is SkQ1H2 (page 8, paragraph [0016]; page 45, claim 19) which is the reduced form of SkQ1 (pages 14-15, paragraph [0067])
Thus, the teachings of Skulachev anticipate the method of instant claims 1-2 and 8.
Response to Arguments
Applicant argues:
Applicant contends both Skulachev ‘591 and Skulachev ’236 fail to present enabling disclosure for treating or preventing a severe inflammatory condition associated with the newly amended claim limitations of severe infection, septic shock, cytokine storm or SIRS,PAMPS, DAMPS, cold shock, heat shock or toxic shock.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The ‘591 application provides examples centered around treating an Acute Pyelonephritis (herein referred to as APN) model in rats wherein bacteria was injected into the bladder, leading to severe infection; noting that treatment with MTAs significantly increases survival of animals with severe APN (page 18, paragraph [0074]; page 26, paragraphs [0103-0105]). The ’236 application has direct support for septic shock as discussed in the above rejection.
Conclusion
Claims 1-2, 7-9 and 11 are rejected.
No claim is allowed
THIS ACTION IS MADE FINAL. 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.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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