DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 7/24/26 has been entered.
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 7-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Geetha (IN-2004CH00392A; submitted by applicant on 7/24/26) in view of Santos et al (Life sciences, 2004, 75, 1917-1924).
Scope of prior art
Geetha teaches dibenzo alpha pyrones (DBP), including 3,8 dihydroxy DBP (urolithin A) as being helpful in alleviating inflammatory conditions and prostaglandin mediated allergic conditions that can be used orally or topically (4th page, Detailed description, first two paragraphs).
Ascertaining the difference
Geetha does not teach an oral composition comprising urolithin A in combination with creatine. Geetha also does not teach the amount of Urolithin A in the composition.
Secondary reference
Santos teaches that creatine supplementation reduces increase in PGE2 and TNF-α both of which are markers for muscle inflammation. Muscle inflammation is an inflammatory condition.
Obviousness
A skilled artisan prior to the earliest effective filing date of the current application, would have found it obvious to combine creatine and Urolithin A into a single dose oral formulation. Geetha teaches that Urolithin A can be administered to alleviate an inflammatory condition. Santos teaches that creatine alleviates muscle inflammation, which is an inflammatory condition. Since both agents are described as having utility in alleviating an inflammatory condition, it would have been obvious to make a single formulation comprising Urolithin A and creatine with an expectation that the formulation would have utility in alleviating an inflammatory condition, specifically muscle inflammation.
2144.06 Art Recognized Equivalence for the Same Purpose [R-08.2012]
I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
“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 reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In reCrockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parteQuadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
With regards to specific amounts of each agent present in the composition, a skilled artisan would have found it obvious to determine the optimal amount of Utolithin A and creatine to add to the composition. Dose optimization is well within the real of routine experimentation. Applicants can overcome this rejection by demonstration of unexpected results derived from administration of a specifically claimed dose.
Conclusion
Claims 1 and 7-30 are pending
Claims 1 and 7-30 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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