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 .
DETAILED ACTION
Pursuant to the amendment dated 02/13/2026, claims 1, 4, and 9 were amended, claims 11-22 were canceled, and claims 23-26 was newly added. Claims 1-10 and 23-26 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/081828, filed on 11/16/2021 and claims foreign priority to EPO 20208386.1 filed on 11/18/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 11/14/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS document has been placed in the application file and the information therein has been considered as to the merits.
Withdrawn Objections
Applicant’s amendment, filed on 02/13/2026, with respect to the objection of claim 1 for informalities, has been fully considered and is persuasive. Applicant amended claim 1 to remove the phrase “and” located right before “(iv)” and added the phrase “and/or” before the “(vi)”. The objection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are modified and new ground(s) necessitated by Applicants' amendment, filed on 02/13/2026, wherein instant independent claims 1 and 9 were amended to alter the breadth and scope of claim 1, wherein the pending claims 2-10 depend from said independent claim 1, and claims 23-26 were newly added.
New and Modified Grounds of Rejection
Claim Rejections - 35 USC § 103
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, 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 1-10, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Firger et al. (US 2020/0197356 A1, published 06/25/2020, see IDS dated 05/18/2023) and as evidenced by Chen et al. (J. of Food Quality, published 03/14/2017, see PTO-892).
Firger is drawn to a formulation comprising at least one ketogenic agent, at
least one cannabinoid, at least one polyphenol, at least one phytonutrient, at least one dietary nutrient, at least one antioxidant, and at least one mineral, and mixtures and
combinations thereof utilized for performance, cardiometabolic, cognitive, and women's health and wellness (abstract). Firger teaches the invention relates to the modulation of metabolic pathways to benefit human performance, endurance and cardiometabolic health while improving cognition and executive brain function and enhancing women’s health. The invention utilizes high concentration ketogenic agent formulations including medium chain triglycerides (MCT), cannabinoids, dietary polyphenols, phytonutrients, other dietary nutrients, antioxidants and minerals to supplement the usual biochemical pathways which generate energy in the brain and body, provide cardiometabolic- and neuroprotection, and diminish adverse age-related health effects in women and improve general health (paragraph 0001). The composition may comprise at least one each of a ketogenic agent, a cannabinoid, and a polyphenol and may optionally further include other dietary nutrients (paragraphs 0073-0078). Firger teaches that the polyphenol may be olive leaf (paragraph 0072). Olive leaf’s primary active substance is oleuropein (paragraph 0106). Firger teaches that the other dietary nutrients can be nicotinamide riboside (NR) (paragraph 0072). Firger teaches that NAD levels decrease with advancing age and under metabolic stress and therefore an elderly population would be one with a NAD deficiency disorder. Supplementation of NR has been demonstrated to help support many aspects of healthy aging, including cardiovascular and brain health. It also helps generate energy in mitochondrial-dense tissues like muscle, brain, and liver. Firger teaches that NR is an optional adjunctive ingredient for further energy and performance support (paragraph 0120). Firger claims a composition that includes, amongst other components, olive leaf from about 25 mg to about 400 mg and nicotinamide riboside from about 100 mg to about 2000 mg (claim 16).
Regarding instant claim 4, Firger teaches that the doses of the composition are intended to be considered the total daily dose and may be consumed at one time or in multiple divided doses throughout the day (paragraph 0070). The dosages and dose ranges of the invention were formulated for wide applicability to account for the fact that less than 100% of the nutrient supplements are generally absorbed and constructed to provide rational usage discretion and dose flexibility. The primary doses and ranges are designed to be at adequately broad and sufficient levels to impart the desired beneficial effects on performance, cardiometabolic, cognitive and women’s health in humans of a wide range of ages and weights (paragraph 0143). Therefore, it would be reasonable to expect that the composition may be consumed for as long as necessary to provide the desired beneficial effects.
Regarding instant claim 5, the claim depends from instant claim 1 and recites the limitation “oleuropein and/or a metabolite thereof” thereby not limiting instant claim 1 to the metabolite of oleuropein. Thus, the limitation of instant claim 5 is met by the prior art teaching the presence of oleuropein.
Regarding instant claim 6, Firger teaches the composition is a comprehensive nutrient formulation (paragraph 0005).
Regarding instant claim 7, Firger teaches that the composition may be provided in a platform for human consumption such as a liquid beverage, powders, and capsules (paragraph 0071).
Regarding instant claim 8, Firger teaches a composition that comprises components that contain protein, carbohydrates, and fats. The composition comprises MCT oil and coconut oil which are fats, and Maca (claim 16). As evidenced by Chen, Maca does contain proteins, fats, and carbohydrates (Table 2, page 4).
Regarding instant claims 9 -10, Firger teaches that the NR is particularly effective at producing NAD which is critical for human metabolism, cellular function, transfer reactions and DNA repair. NAD is a requisite in enabling cells to produce energy in the mitochondria and works synergistically with other energy sources such as
ketones. It is also an important substrate for NAD-consuming enzymes including the sirtuins, that have potential beneficial effects on aging and circadian rhythms, and poly
ADP-ribose polymerases, a family of proteins involved in essential cellular functions including genomic stability, DNA repair and programmed cell death, or apoptosis (paragraph 0119). Extensive research studies show that NAD levels decrease with advancing age and under metabolic stress and supplementation of NR has been demonstrated to help support many aspects of healthy aging (paragraph 0120). Further, the phytonutrients in the composition provide benefits such weight control (paragraph 0004).
Regarding instant claims 23 and 25, Firger teaches that the composition may comprising 25-200 mg olive leaf, which is comprised of 10-30% oleuropein, and 100-2000 mg NR (paragraph 0072). The amounts are intended to be considered the total daily dose (paragraph 0070).
Firger is silent to the method of “increasing mitochondrial calcium uptake” which is a limitation in instant claim 1. Firger teaches that the population that would benefit from the composition includes those that would see a “diminish of adverse age-related health effects” (abstract) which indicates an older population. The instant specification teaches the population is an older adult or an elderly individual (instant paragraph 0001). Since Firger is administering the same active ingredients, oleuropein and NR, to the same elderly human population, the composition taught by Firger must also be able to achieve the limitation of increasing mitochondrial calcium uptake. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Firger does not exemplify the administration of the composition to a subject.
It would have been prima facie obvious before the effective filing date to administer a subject a composition comprising oleuropein and nicotinamide riboside to improve a physiological state related to NAD deficiency, improve a physiological state linked to metabolic fatigue, increase mitochondrial energy and enhance mitochondrial function as taught by Firger to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to administer the composition comprising oleuropein and NR to a subject to improve a physiological state related to NAD deficiency, improve a physiological state linked to metabolic fatigue, increase mitochondrial energy and enhance mitochondrial function because Firger teaches a composition comprising oleuropein and NR and teaches that the composition may modulate metabolic pathways to benefit human performance, endurance and cardiometabolic health while improving cognition and executive brain function. One of ordinary skill in the art would have a reasonable expectation of success because Firger teaches a composition comprising oleuropein and NR and teaches that the composition may modulate metabolic pathways to benefit human performance, endurance and cardiometabolic health while improving cognition and executive brain function.
Regarding instant claims 23 and 25, it would have been prima facie obvious before the effective filing date of the claimed invention to optimize the amounts of the oleuropein to be between 0.01 mg/d to 0.9 g/day and the NR to be between 0.01 mg/d to 0.9 g/day to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the amounts of oleuropein to be between 0.01 mg/d to 0.9 g/day and the NR to be between 0.01 mg/d to 0.9 g/day because Firger teaches that the composition may comprising 25-200 mg olive leaf which is comprised of 10-30% oleuropein and 100-2000 mg NR. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Firger et al. (US 2020/0197356 A1, published 06/25/2020, see IDS dated 05/18/2023) as applied to claims 1 and 9 above, and further in view of Xu et al. (Frontiers in Chemistry, published 08/12/2018, see PTO-892).
Claims 1 and 9 are rejected as discussed above.
The teachings of Firger are discussed above.
Firger does not specify that the oleuropein is in the form of oleuropein aglycone.
Xu is drawn to the review of oleuropein aglycone (title). Oleuropein aglycone (OA) is the major phenolic component of extra virgin olive oil and has pharmacological effects including anti-Alzheimer’s disease, anti-breast cancer, anti-inflammatory, anti-hyperglycemic, anti-oxidative, and lipid-lowering properties (abstract). OA provides neuroprotection to cultured neuronal cells and murine models by intervening with Ab
aggregation, decreasing aggregate cytotoxicity, and counteracting related neuroinflammation (page 6). OA offsets amyloid aggregation and the toxicity affects different pathways: amyloid precursor protein processing, Ab peptide and tau aggregation, autophagy impairment, and neuroinflammation (page 7).
It would have been prima facie obvious to combine the teachings of Firger and Xu before the effective filing date of the claimed invention by substituting OA as taught by Xu as the form of oleuropein in the composition taught by Firger to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to substitute OA because Xu teaches that OA provides neuroprotection and Firger teachings administering a composition comprising oleuropein for neuroprotection. One of ordinary skill in the art would have a reasonable expectation of success because Xu teaches that OA provides neuroprotection and Firger teachings administering a composition comprising oleuropein from olive leaf for neuroprotection.
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered in so much as they apply to the amended claims but they are not persuasive.
Applicant argues that Firger does not administer the same active ingredients to the same population and therefore the office cannot claim of inherency regarding the composition of Firger increasing mitochondrial calcium uptake. Applicant argues that the instant population is not limited to only an elderly human population and that the elderly human population is just one embodiment of the population. Further, the applicant argues that when considering unexpected synergistic results to overcome a case of prima facie obviousness, the critical inquiry is whether the skilled artisan would have found the results of the combination of references to be unexpected, not whether the results would have been inherent or not. The arguments are unpersuasive. The elderly adult or individual would be considered one population of the instant specification. The instant specification does not state that the mechanism of increased mitochondrial calcium uptake is not seen in the elderly population. Therefore, if the mechanism of increased mitochondrial calcium uptake due to the administration of oleuropein and NR to an elderly population in the instant specification, it would necessarily flow that the administration of oleuropein and NR to an elderly population in Firger would result in an increased mitochondrial calcium uptake in the elderly population of Firger. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
The instant specification was reviewed for evidence of unexpected results. The instant specification suggests that the combination of oleuropein and nicotinamide riboside has a synergistic effect in the increase of mitochondrial Ca2+ and increased lifespan of the cells in a NAD depleted subject (instant specification paragraph 0013-0014). The results support the synergistic effect (instant Figures 2 and 4). Should the applicant be able to further distinguish from the populations of Firger and the instant claims to be commensurate in scope with the data provided in the instant specification, the results would support the scope of increasing mitochondrial energy and mitochondrial calcium uptake, enhancing mitochondrial function, and improving healthspan in an individual having a NAD deficiency/restrictive disorder in instant claim 1.
Conclusion
No claims are 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.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693 /SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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