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 1-18 are pending in the instant application.
Information Disclosure Statement
The Information Disclosure Statement received April 1st, 2026 has been fully considered by the examiner, except where marked with a strikethrough.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejection of Claims 2, 4, and 13-15 under 35 U.S.C. 112(b). This rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of Claims 1-16 under 35 U.S.C. 103 as being unpatentable over Auwerx et. al. (WO 2018/108991 A2; cited in non-final office action mailed January 27th, 2026; hereinafter referred to as Auwerx) is maintained and extended to newly presented Claims 17-18.
Applicant traverses this rejection beginning at Page 7 of the remarks received June 23rd, 2026.
First, Applicant traverses the rejection on the basis that though Auwerx teaches compounds that enhance mitochondrial proteostasis, these are organized into four distinct functional categories. Further, Applicant notes that, among others, Urolithin A and Urolithin B are categorized as compounds that induce mitophagy and fibrates such as fenofibrate or bezafibrate, among others are categorized as compounds that modulate lipid metabolism. Applicant further notes that arriving at the instantly claimed composition would require independent selections from compounds categorized as inducing mitophagy and compounds that modulate lipid metabolism, asserting that insufficient direction from Auwerx is present to direct a person having ordinary skill in the art to do so.
Beginning at the last paragraph of Page 8 of the remarks, Applicant asserts that the reasoning under In re Kerkhoven relied upon in the non-final rejection is erroneous, noting that Auwerx is directed to methods of treating amyloid-β peptide diseases and that, by contract, the instant claimed invention is directed to pharmaceutical compositions for use in the treatment of cardiac diseases.
Finally, at the second paragraph of page 10, Applicant claims unexpected results with respect to cardiac-specific efficacy results that were not suggested by Auwerx.
The examiner does not find these arguments persuasive.
Applicant distinguishes the mechanism by which compounds such as Urolithin A and Urolithin B versus bezafibrate and fenofibrate enhance mitochondrial proteostasis. This is moot, as despite the distinct mechanisms of action, Urolithin A, Urolithin B, bezafibrate, and fenofibrate are recognized in the prior art by Auwerx as enhancing mitochondrial proteostasis. Therefore, a person having ordinary skill in the art would have found it prima facie obvious to generate, for example, a pharmaceutical composition comprising fenofibrate and Urolithin A, due to the recognition in the art that each of these compounds are useful for the same purpose. As the instant claims are drawn to a composition, this motivation is sufficient to direct a person having ordinary skill in the art to generate the instantly claimed composition, as per MPEP 2144.06, I., “”It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…. [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F. 2d 846, 850, 205 USPQ 1068, 1072 (CCPA 1980)”.
Regarding Applicant’s statement that relying on In re Kerkhoven is erroneous due to Auwerx teaching compositions useful for treating amyloid-β diseases whereas the instant application is directed to compositions for use in the treatment of cardiac diseases. This reasoning is moot, as the instant claims are drawn toward compositions. Applicant’s distinction is being drawn between methods of using these compositions. This, however, is not relevant to the instant claims, as the instant claims are drawn to compositions, not methods of use thereof. Therefore, the common function of the compounds, i.e. enhancing mitochondrial proteostasis, as established by Auwerx sufficiently motivates a person having ordinary skill in the art to combine the aforementioned compounds in a single composition.
Similarly, Applicant’s claim of unexpected results relating to cardiac-specific efficacy is moot. As noted in the non-final rejection, the recitations of intended use in instant Claims 8-16 do not introduce further limitations of the composition and do not carry patentable weight. In other words, what is being examined instantly are claims drawn to a composition comprising a PPAR-modulator and a compound of formula I.
For these reasons, and for those already of record as noted in the non-final rejection mailed January 27th, 2026, Claims 1-18 are rejected.
Conclusion
Claims 1-18 are rejected.
No claim is 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 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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