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 .
Applicant’s amendment of claims 1 and the addition of new claims 2-6, in the paper of 11/17/2025, is acknowledged. Applicants' arguments filed on 11/17/2025, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claim 1-6 are at issue and are present for examination.
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 1-6 is 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 1 (claims 2-6 dependent from) is indefinite in that it is drawn to a method for improving mitochondrial functions in cells of a subject having a condition associated with decreased mitochondrial membrane potential, comprising: (a) administering a composition and (b) increasing the mitochondrial potential in the subject's cells. The claimed method is indefinite in that while it comprises (a) administering a composition, it is indefinite with regard to (b) increasing the mitochondrial potential in the subject's cells, as it is unclear how (b) relates to (a) and the claimed method. While it is acknowledged that part (b) recites increasing the mitochondrial membrane potential in the subject's cells by the administered reactive persulfide, thereby improving mitochondrial function, it is unclear if part (b) is a result of part (a) or is part (b) in addition to part (a). Does the claimed method comprise (a) administering and (b) increasing, as a result of (a) administering, or does the claimed method comprise (a) administering and (b) increasing, in addition to (b) administering. In the interest of advancing prosecution the claims are given their broadest reasonable interpretation, the first of the above options, that the claimed method comprise (a) administering and (b) increasing, as a result of (a) administering.
Claim 1 (claims 2-6 dependent from) is further indefinite in that it is drawn to “a method for improving mitochondrial functions” said method comprising “thereby improving mitochondrial function”. The claim is indefinite in that it is unclear and confusing with regard to “improving mitochondrial functions” and “improving mitochondrial function” and the relationship between the two. What are the mitochondrial functions and are they different from the mitochondrial function?
Appropriate amendment and/or comment is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 1-6 are directed to all possible methods for improving mitochondrial functions in cells of a subject having a condition associated with decreased mitochondrial membrane potential, comprising: (a) administering to the subject in need thereof a composition comprising a reactive persulfide in an amount effective to increase mitochondrial membrane potential without inhibiting mitochondrial respiratory complex IV: and (b) increasing the mitochondrial membrane potential in the subject's cells by the administered reactive persulfide, thereby improving mitochondrial function (see also above rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph). The specification does not provide a single method for improving mitochondrial functions in cells of a subject having a condition associated with decreased mitochondrial membrane potential, comprising: (a) administering to the subject in need thereof a composition comprising a reactive persulfide in an amount effective to increase mitochondrial membrane potential without inhibiting mitochondrial respiratory complex IV: and (b) increasing the mitochondrial membrane potential in the subject's cells by the administered reactive persulfide, thereby improving mitochondrial function, encompassed by these claims. There is no disclosure of the effective amount of reactive persulfide to increase mitochondrial membrane potential without inhibiting mitochondrial respiratory complex IV in the claimed method. General Hospital Corporation (WO 2021/231476) disclose methods for the treatment, or reduction of risk, of a disorder associated with neurodegeneration in a subject, the method comprising administering a therapeutically or prophylactically effective amount of a composition prepared using crystals of Glutathione Trisulfide (GSSSG) to a subject in need thereof wherein the amount is 282 µM. While applicants specification describes methods of administration of NaHS to yeast cell cultures at 3 to 10 µM applicants specification fails to disclose those amounts effective to increase mitochondrial membrane potential without inhibiting mitochondrial respiratory complex IV in the claimed methods, for which no predictability is apparent.
Given the lack of disclosure of methods encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
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.
(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.
The rejection of claim(s) 1 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Goubern et al. (FASEB J., Vol 21, pp 1699-1706, June 2007) as evidenced by Landry et al. (Cell Chemical Biology, 26, pp 1515-1525, Nov 2019) is withdrawn based upon applicants amendment of the claims and applicants arguments presented in the paper of 11/17/2025. Specifically Goubern et al. does not teach administering to the subject in need thereof a composition comprising a reactive persulfide. Goubern et al. disclose administering a sulfide.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102) (a)(2) as being anticipated by General Hospital Corporation (WO 2021/231476).
General Hospital Corporation (WO 2021/231476) teach a method for the treatment, or reduction of risk, of a disorder associated with neurodegeneration in a subject, the method comprising administering a therapeutically or prophylactically effective amount of a composition prepared using crystals of Glutathione Trisulfide (GSSSG) to a subject in need thereof. While General Hospital Corporation may not teach that as a result of the above administering of GSSSG, increasing the mitochondrial membrane potential in the subject’s cells this is considered an inherent result of the administration of GSSSG taught by General Hospital Corporation.
Thus claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102) (a)(2) as being anticipated by General Hospital Corporation (WO 2021/231476).
Related Art not used in a Rejection
Babidge et al., Molecular and Cellular Biochemistry, Vol 181, pp 117-124, 1998.
Remarks
No claim is allowed.
Conclusion
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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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rgh
1/8/2025
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652