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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 03 April 2026, in which claims 1, 5, 10, and 12 are amended to change the scope and breadth of the claim, and new claims 26-28 are added.
This application is the national stage entry of PCT/EP2022/054560, filed 23 Feb 2022; and claims benefit of foreign priority document EP 21159707.5, filed 26 Feb 2021. This foreign priority document is in English.
Claims 1-12 and 26-28 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s amendment, filed 03 April 2026, with respect that claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been fully considered and is persuasive, as amended claim 5 does not recite derivatives thereof.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, Fowler et al. does not disclose the method meeting each and every limitation of the claimed invention.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, De Marchi et al. alone does not teach or fairly suggest the method meeting each and every limitation of the claimed invention.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-10, 16-17, and 20-21 of copending Application No. 17/740607 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 17, and 19-24 of copending Application No. 17/736,496 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13, and 15-19 of copending Application No. 18/250,874 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/862,394 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/866,347 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Applicant’s amendment, filed 03 April 2026, with respect that claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/866,329 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) has been fully considered and is persuasive, as amended claims 1, 10, and 12 recite the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6. Upon reconsideration, the combined teachings of reference claims in view of Fowler et al. does not teach or fairly suggest the method meeting each and every limitation of the claimed invention because the primary teachings of the reference claims do not provide guidance for selecting this particular dosage range.
This rejection has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: upon reconsideration, claim 1 recites a method for use in a list including items (i), (ii), (iii), and (iv), however the list recites “(i) …, (ii) …, and (iii) …, (iv) …” (emphasis added). The conjunction “and” should appear before the last item in the list.
Appropriate correction is required.
The following are new or modified grounds of rejection necessitated by Applicant’s amendment, filed 03 April 2026, in which claims 1, 5, 10, and 12 are amended to change the scope and breadth of the claim, and new claims 26-28 are added.
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.
Amended Claims 1-6, 10-11, 26, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stampalia (US 2020/0000768, published 02 Jan 2020, cited in PTO-892).
Stampalia discloses a composition and method of use for the general improvement of hypertension, high cholesterol, and cardiovascular health. The composition comprises thiamin (vitamin B1), vitamin B2 (as riboflavin-5’-phosphate), niacin (vitamin B3, as niacinamide), vitamin B6 (as pyridoxine hydrochloride), folic acid, vitamin C, vitamin D, calcium (as calcium carbonate), magnesium (as magnesium taurate), aged garlic extract, olive leaf extract (as 20% oleuropein), coenzyme Q10 (as ubiquinol), L-Arginine (as hydrochloride), L-Citrulline (as malate), and lycopene (abstract), or the composition administered comprising vitamin B6, oleuropein, calcium, and minerals and vitamins. The preferred amount per serving of the ingredients of the composition are 2 mg of vitamin B6 and 500 mg olive leaf extract (20% oleuropein), meaning 100 mg oleuropein, and 200 mg calcium (page 3, table 1), meeting limitations of claim 1, 10, and 28. The composition is preferably administered in a single dose in the morning. To achieve the maximum benefit, the composition is self-administered once daily (page 2, paragraph 24), or a daily dosage of the composition meeting limitations of claims 1 and 10. In one dosing protocol, the subject self-administers the composition orally upon waking in the morning. This continues each morning until a medical practitioner recommends changes. It may require a period, such as one month before benefits are realized, whether anecdotally or analytically (page 2, paragraphs 24-25), implying daily oral administration over a period such as one month and meeting limitations of claim 4. The effects of the treatment are the reduction of blood pressure (hypertension), decreased inflammation, decreased oxidative stress, and favorable vascular immune function (page 3, paragraph 42), meeting limitations of claim 1. Some embodiments provide for a composition useful in treating or improving hypertension, high cholesterol, and cardiovascular health overall (page 1, paragraph 10). In any of the embodiments presented herein, the subject referred to herein may or may not suffer from one or more of diseases or disorders selected from the group consisting of cardiovascular disease, atherosclerosis, heart failure, hypercholesterolemia, and inflammation associated with pain (page 2, paragraph 17), where hypercholesterolemia is a type of hyperlipidemia, meeting limitations of claims 10-11.
Regarding claims 5 and 26, the claims recite further limitations of the metabolite of oleuropein. However, claim 1 recites “oleuropein and/or a metabolite thereof”, and is interpreted as recite the metabolite thereof as an alternative. In this case the language of claims 5 and 26 do not require the alternative of the metabolite of oleuropein, and are interpreted to encompass the alternative of the oleuropein disclosed in Stampalia.
Regarding claim 1, Stampalia is silent as to the method for use in all of (i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, and (iv) treating or preventing a calcium deficiency/depletion disorder. Regarding claims 2, Stampalia is silent as to the body part of the one or more cells affected by the method. Regarding claim 3, Stampalia is silent to the physiological state linked to metabolic fatigue improved. MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case Stampalia discloses the method wherein the composition administered includes oleuropein, vitamin B6, and calcium administered in the same daily dosage as claimed, and discloses the method for use in treating or improving high cholesterol and reducing oxidative stress, therefore there is reason to believe the subject matter disclosed in the prior art inherently includes the functions that are newly recited.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Amended Claims 1-12 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Fowler et al. discloses hydroxytyrosol in combination with at least one of the compounds selected from the group including vitamin B6 used to maintain or increase mitochondrial biogenesis in cardiac muscle, skeletal muscles, and liver tissue (abstract), addressing limitations of claim 1-2 and 5. The use of the phrase “hydroxytyrosol in combination with at least one of the compounds selected from the group consisting of …” is intended to include each single combination of hyroxytyrosol with each of the individual compounds within the group (page 2, paragraph 14). In yet another embodiment, the hydroxytyrosol is used in combination at least one of the compounds selected from the group consisting of caffeine, carnitine, and a B Vitamin (page 3, paragraph 53). Fowler et al. discloses the effective dosage of each of hydroxytyrosol and vitamin B6 in their invention, where the daily dosage of hydroxytyrosol for humans is preferably from 5 to 100 mg, and Vitamin B6 dosages are typically from 0.1-20 mg per day per person (page 7, paragraphs 110-112 and 126), addressing limitations of claims 1, 10 and 12. Effects of increased mitochondrial function and/or mitochondrial biogenesis include observations that the combination helps promote endurance, helps promote recovery after exercise, helps reduce muscle fatigue, and helps boost body's own energy production in a natural sustained way (page 2, paragraphs 16-45), addressing limitations of claims 3 and 12. In working example 2, the mouse animal model is treated with the composition orally daily for 3 weeks (page 9, paragraph 151-153), addressing limitations of claim 4. The combination can be formulated as a food product or a beverage; a dietary supplement in forms such as tablets, capsules, softgels, gelcaps, liquids, or powders; or a nutraceutical composition which can further comprise usual additives, for example sweeteners, flavors, sugar, fat, emulgators, preservatives, or additional vitamins (page 6, paragraphs 104-106), addressing limitations of claims 6-9. Mitochondrial function, thus available energy, decreases with aging. Thus, another preferred embodiment of the invention is also energy products formulated for people aged over 50, looking to maintain a youthful energy level, so as to maintain an active lifestyle (paragraph 79, spanning pages 4-5), or treating the condition of physiological ageing and administering to an older adult, addressing limitations of claims 10-12. Fowler et al. discloses the combination of hyroxytyrosol with the individual compounds provides synergistic effects (page 4, paragraph 69; example 15 at page 10, paragraphs 166-168). Fowler et al. teaches in further embodiments of the invention, hydroxytyrosol derivatives such as esters and physiologically or pharmaceutically acceptable salts may be used instead of or in addition to hydroxytyrosol. Preferred esters of hydroxytyrosol are e.g. acetates or glucuronide conjugates; as well as oleuropein being the most preferred one (paragraph 50 spanning pages 2-3), or the alternative of oleuropein addressing claims 1, 10, 12, and 26.
Fowler et al. does not specifically disclose the method wherein the composition is administered to provide a daily dose of 0.001 mg to 1.0 g oleuropein and/or a metabolite thereof and a daily dosage of about 0.2-300 mg vitamin B6 (claims 1, 10, and 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of Fowler et al. in order to select the optimal dose of the specific combination of hydroxytyrosol and vitamin B6 or oleuropein and vitamin B6. One of ordinary skill in the art would have been motivated to modify Fowler et al. with a reasonable expectation of success because Fowler et al. teaches each single combination of hyroxytyrosol with each of the individual compounds within the group, suggesting motivation to pick-and-choose each combination such as the combination of hyroxytyrosol and vitamin B6, and teaches the effective dosage of each of hydroxytyrosol and vitamin B6 in their invention, where the daily dosage of hydroxytyrosol for humans is preferably from 5 to 100 mg, and Vitamin B6 dosages are typically from 0.1-20 mg per day per person, suggesting it would have been obvious to select the optimal effective dosage of each active agent through routine experimentation from the disclosed range. See also MPEP 2144.05 at I. providing “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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)” In this case Fowler et al. teaches an overlapping range for the dosage of the vitamin B6, and teaches the compounds administered for use in a method having a same intended result as claimed, suggesting that the claimed range for the dosage of the vitamin B6 which overlaps with the range disclosed in the prior art would have been prima facie obviousness. Regarding claim 27, Fowler et al. suggests the single combination of hyroxytyrosol with each of the individual compounds, suggesting it would have been obvious to select the composition administered to comprise only these two components as the active agent. Regarding claim 26, Fowler et al. teaches oleuropein being the most preferred hydroxytyrosol derivative used instead of hydroxytyrosol, suggesting the method wherein comprising administering oleuropein and vitamin B6, which is encompassed within the scope of claim 26.
Regarding claim 1, Fowler et al. is silent as to the method for use in all of (i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, and (iv) treating or preventing a calcium deficiency/depletion disorder. MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case Fowler teaches the method wherein the composition administered includes hydroxytyrosol and vitamin B6 or oleuropein and vitamin B6 administered in the same daily dosage as claimed, and teaches the method for use to maintain or increase mitochondrial biogenesis in cardiac muscle, skeletal muscles, and liver tissue, and to reduce muscle fatigue, therefore there is reason to believe the subject matter taught in the prior art inherently includes the functions that are newly recited. MPEP 2112 provides “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995)
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Regarding the dosage of the hydroxytyrosol and vitamin B6 or oleuropein and vitamin B6 administered, in the modified grounds of rejection detailed above Fowler et al. is newly cited to teach the effective dosage of each of hydroxytyrosol and vitamin B6 in their invention, where the daily dosage of hydroxytyrosol for humans is preferably from 5 to 100 mg, and Vitamin B6 dosages are typically from 0.1-20 mg per day per person, suggesting it would have been obvious to select the optimal effective dosage of each active agent through routine experimentation from the disclosed range. The daily dosage of hydroxytyrosol of 5 to 100 mg is completely within the claimed range. As detailed in the modified grounds of rejection, Fowler et al. teaches an overlapping range for the dosage of the vitamin B6, and teaches the compounds administered for use in a method having a same intended result as claimed, suggesting that the claimed range for the dosage of the vitamin B6 which overlaps with the range disclosed in the prior art would have been prima facie obviousness.
Applicant remarks that Fowler et al. does not disclose the specific combination of hydroxytyrosol and vitamin B6 or oleuropein and vitamin B6 to be administered in the method, and that the only example of Fowler testing synergistic effects is for HT in combination with L-carnitine. However, as detailed in the rejection of record, Fowler et al. teaches the use of the phrase “hydroxytyrosol in combination with at least one of the compounds selected from the group consisting of …” is intended to include each single combination of hyroxytyrosol with each of the individual compounds within the group (page 2, paragraph 14), meaning that Fowler et al. itself provides guidance for picking-and-choosing the each single combination of hyroxytyrosol with each of the individual compounds within the group. Regarding the disclosed examples in Fowler et al., MPEP 2123 at II. provides “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” and “Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” In this case the disclosed example does not teach away from the broader disclosure of Fowler et al., and as discussed above Fowler et al. provides guidance for the alternatives of each single combination of hyroxytyrosol with each of the individual compounds within the group.
Applicant remarks that the claimed invention provides synergistic activation of mitochondria via Ca2+ increase in mitochondrial cells. However, this experimental data is provided with the compounds administered as in vitro concentrations, and it is unclear how these values translate to the daily dosages of the claimed invention and whether the provided data is commensurate in scope with the claimed invention. Further, regarding the amended claims, the closest prior art embodiment is deemed to be Stampalia (US 2020/0000768, published 02 Jan 2020, cited in PTO-892) detailed in the new grounds of rejection above. No comparison is of record between the claimed invention and this closest prior art embodiment. Therefore Applicant’s remarks that the claimed invention is non-obvious due to secondary considerations such as unexpected results is not persuasive.
Amended Claims 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023) as applied to claims 1-12 and 26-27 above, and further in view of De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023).
Fowler et al. teaches as above regarding claims 1-12 and 26-27.
Fowler et al. does not specifically teach the method wherein the metabolite of oleuropein is oleuropein aglycone, elenolic acid, homovanillyl alcohol, isohomovanillyl alcohol, and mixtures thereof (claim 26). Fowler et al. does not specifically teach the method wherein the composition administered further comprises calcium and provides a daily dosage of 0.1 to 1.0 g of the calcium (claim 28).
De Marchi et al. teaches a combination of calcium and at least one of oleuropein or metabolite thereof can be orally administered to an individual in an amount effective to achieve at least one result that is (i) improved mitochondrial calcium uptake in muscle cells, (ii) improved utilization of calcium in muscle cells, (iii) increased mitochondrial energy in muscle cells, (iv) improvement in at least one of muscle functionality, muscle performance, or muscle strength, (v) decreased muscle fatigue, (vi) increased mobility, and/or (vii) treatment of a muscle disorder linked to calcium depletion or deficiency (abstract), addressing limitations of the condition treated of claims 1, 3, and 10-12. In an embodiment at least a portion of the muscle cells are part of a skeletal muscle (page 3, paragraph 8), addressing limitations of claim 2. In an embodiment the combination of calcium and at least one of oleuropein or metabolite thereof is administered to the individual for a time period of at least one month, most preferably for at least one year. During the time period, the combination is most preferably administered seven days per week, or daily (page 18, paragraph 90), addressing limitations of claim 4. In an embodiment, the metabolite of oleuropein is selected from the group consisting of oleuropein aglycone, hydroxytyrosol, homovanillyl alcohol, isohomovanillyl alcohol, glucuronidated forms thereof, sulfated forms thereof, derivatives thereof, and mixtures thereof (page 3, paragraph 10), addressing limitations of claim 5 and 26. In embodiments the composition can comprise a food additives such as vitamins and minerals (page 4, paragraph 20; page 19, paragraph 97), addressing limitations of claim 6. Examples of suitable vitamins include vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride) (paragraph 103 spanning pages 20-21). The combination can be administered to the individual in a beverage, a food product, a capsule, a tablet, a powder or a suspension (page 16, paragraphs 79-80), addressing limitations of claim 8-9. In a general embodiment, 0.001 mg to 1.0 g of the at least one of oleuropein or metabolite thereof can be administered to the individual per day, most preferably from 1.0 mg to 200 mg of the at least one of oleuropein or metabolite thereof per day (paragraph 71 spanning pages 14-15). In a general embodiment, 0.1 g to 1.0 g of the calcium is administered to the individual per day (page 15, paragraph 72), addressing limitations of claim 28.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Fowler et al. in view of De Marchi et al. in order to further administer calcium in the method of Fowler et al., or to select the oleuropein derivative to be a metabolite of oleuropein. One of ordinary skill in the art would have been motivated to combine Fowler et al. in view of De Marchi et al. because both Fowler et al. and De Marchi et al. teach administration of a combination of agents including oleuropein or hydroxytyrosol in a similar dosage in order to increase mitochondrial energy in muscle cells, and Fowler et al. teaches the administration of a combination of agents, suggesting it would have been obvious to administer a combination of agents known for the same purpose with a reasonable expectation of success. Regarding claim 26, Fowler et al. teaches in further embodiments of the invention, hydroxytyrosol derivatives may be used instead of or in addition to hydroxytyrosol, such as oleuropein, and De Marchi et al. teaches metabolite of oleuropein such as hydroxytyrosol are known to be used for the same purpose, suggesting it would have been obvious to select the hydroxytyrosol derivative to be a metabolite of oleuropein as taught by De Marchi et al.
Response to Applicant’s Remarks:
Applicant’s remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding Fowler et al. are addressed as above.
Regarding the teachings of De Marchi et al. alone, Applicant’s amendment is persuasive as detailed above.
In the new grounds of rejection, the teachings of De Marchi et al. are combined with the method taught by Fowler et al. in order to administer calcium in the method of Fowler et al. for the reasons detailed in the new or modified grounds of rejection detailed above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Amended Claims 1-12 and 26-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-11, and 21-25 of copending Application No. 17/595,166 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 1, 4, 6-8, and 21-25 of the reference application are drawn to treatment or prevention of a calcium deficiency/depletion disorder, the method comprising orally administering an effective amount of at least one of oleuropein, homovanillyl alcohol, and isohomovanillyl alcohol, to the individual. Reference claim 4 recites the composition orally administered daily for at least one week, corresponding to claim 4. Reference claim 6 recites the form of the composition, corresponding to claim 7. Reference claim 8 recites the food product further comprising components, corresponding to claim 9. Reference claims 9-11 are drawn to a method of treating or preventing a mitochondria-related disease or a condition associated with altered mitochondrial function in an individual in need thereof or at risk thereof, the method comprising orally administering an effective amount of at least one of oleuropein or metabolite thereof to the individual in need thereof or at risk thereof. Reference claim 10 recites conditions corresponding to claim 11. Reference claims 7 and 21 recites the composition comprises calcium in an amount from about 200 mg to about 800 mg, addressing limitations of claim 28.
Reference claims 1, 4, 6-11, and 21-25 do not specifically recite the method comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and Vitamin B6 (claims 1, 10, and 12).
Fowler et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1, 4, 6-11, and 21-25 in view of Fowler et al. in order to combine the method of administering oleuropein of the Reference claims with the combination with vitamin B6 taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1, 4, 6-11, and 21-25 in view of Fowler et al. with a reasonable expectation of success because both the Reference claims and Fowler et al. are drawn to treatment of a mitochondria-related disease or a condition comprising administering oleuropein, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 to provide improved results.
This is a provisional nonstatutory double patenting rejection. However, a Notice of Allowance has been mailed in the copending application on 29 April 2026.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the teachings of Fowler et al. are applicable to the teachings applied in this nonstatutory double patenting rejection, and are addressed as above.
Amended Claims 1-12 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 17/595,159 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Reference claim 10 of the reference application is drawn to a method of achieving at least one result selected from the group consisting of (i) improved mitochondrial calcium uptake in muscle cells, (ii) improved utilization of calcium in muscle cells, (iii) increased mitochondrial energy in muscle cells, (iv) improvement in at least one of muscle functionality, muscle performance, or muscle strength, (v) decreased muscle fatigue, (vi) increased mobility and (vii) treatment of a muscle disorder linked to calcium depletion or deficiency in an individual in need thereof, the method comprising orally administering to the individual an effective amount of a composition comprising a calcium source and the oleuropein. Reference claim 11 is drawn to a unit dosage form comprising a calcium source and the oleuropein, effective for the result of the method of the reference claims, making obvious the use of the claimed dosage form in order to achieve the intended result.
Reference claims 10-11 do not specifically recite the method comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and Vitamin B6 (claims 1, 10, and 12).
Fowler et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-4, 10-12, 18-20, and 27-32 in view of Fowler et al. in order to combine the method of administering oleuropein of the Reference claims with the combination with vitamin B6 taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1-4, 10-12, 18-20, and 27-32 in view of Fowler et al. with a reasonable expectation of success because both the Reference claims and Fowler et al. are drawn to treatment of a mitochondria-related disease or a condition comprising administering oleuropein, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 to provide improved results.
This is a provisional nonstatutory double patenting rejection.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the teachings of Fowler et al. are applicable to the teachings applied in this nonstatutory double patenting rejection, and are addressed as above.
Amended Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11 of copending Application No. 17/595,159 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023), further in view of De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 10-11 of the reference application in view of Fowler et al. teach as above.
Reference claims 10-11 in view of Fowler et al. do not specifically teach the method wherein the composition administered further comprises calcium and provides a daily dosage of 0.1 to 1.0 g of the calcium (claim 28).
De Marchi et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 10-11 in view of Fowler et al. further in view of De Marchi et al. in order to select the dosage of the calcium administered. One of ordinary skill in the art would have been motivated to combine Reference claims 10-11 in view of Fowler et al. further in view of De Marchi et al. with a reasonable expectation of success because all of Reference claims 10-11, Fowler et al., and De Marchi et al. are drawn to a similar method of treatment comprising administering oleuropein, and De Marchi et al. teaches the method of treatment comprising administering the combination of oleuropein and calcium and provides guidance for selecting the effective amount of calcium administered.
Amended Claims 1-12 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over amended claims 1-10 and 23-26 of copending Application No. 18/253,428 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 1-10 and 23-26 of the reference application are drawn to a method including for increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and enhancing mitochondrial function, comprising administering to a subject in need of same, a composition comprising a combination of oleuropein and/or a metabolite thereof and nicotinamide riboside, in a therapeutically effective amount. Reference claim 2-5 corresponds to the limitations of claim 2-5, respectively. Reference claim 6-7 recites the composition in the form of a food product, corresponding to claim 7-8, respectively. Reference claim 8 recites the components of the food product, corresponding to claim 9. Reference claims 9-10 correspond to limitations of claims 10-11. Reference claims 23 and 25 recite the oleuropein and/or a metabolite thereof administered in an amount from 0.01 mg/day to 0.9 g/day. Reference claims 24 and 26 recite the oleuropein and/or a metabolite thereof consists of oleuropein aglycone, addressing limitations of claim 26.
Reference claims 1-10 and 23-26 do not specifically recite the method comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and Vitamin B6 (claims 1, 10, and 12).
Fowler et al. teaches as above.
It would have been obvious to combine Reference claims 1-10 and 23-26 in view of Fowler et al. in order to combine the method of administering oleuropein of the Reference claims with the combination with vitamin B6 taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1-10 and 23-26 in view of Fowler et al. with a reasonable expectation of success because both the Reference claims and Fowler et al. are drawn to treatment of a mitochondria-related disease or a condition comprising administering oleuropein, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 to provide improved results.
This is a provisional nonstatutory double patenting rejection.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the teachings of Fowler et al. are applicable to the teachings applied in this nonstatutory double patenting rejection, and are addressed as above.
Amended Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over amended claims 1-10 and 23-26 of copending Application No. 18/253,428 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023), further in view of De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023).
The Reference claims in view of Fowler et al. teach as above.
The Reference claims in view of Fowler et al. do not specifically teach the method wherein the composition administered further comprises calcium and provides a daily dosage of 0.1 to 1.0 g of the calcium (claim 28).
De Marchi et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Reference claims in view of Fowler et al. further in view of De Marchi et al. in order to select the dosage of the calcium administered. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Fowler et al. further in view of De Marchi et al. with a reasonable expectation of success because all of the Reference claims, Fowler et al., and De Marchi et al. are drawn to a similar method of treatment comprising administering oleuropein, and De Marchi et al. teaches the method of treatment comprising administering the combination of oleuropein and calcium and provides guidance for selecting the effective amount of calcium administered.
Amended Claims 1-12 and 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/547,934 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 1-12 of the reference application are drawn to a method including for increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and enhancing mitochondrial function, comprising administering to a subject in need of same, a composition comprising a combination of oleuropein and/or a metabolite thereof and magnesium, in a therapeutically effective amount. Reference claim 2-12 corresponds to the limitations of claim 2-12, respectively.
Reference claims 1-12 do not specifically recite the method comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and Vitamin B6 (claims 1, 10, and 12).
Fowler et al. teaches as above.
It would have been obvious to combine Reference claims 1-12 in view of Fowler et al. in order to combine the method of administering oleuropein of the Reference claims with the combination with vitamin B6 taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1-11 in view of Fowler et al. with a reasonable expectation of success because both the Reference claims and Fowler et al. are drawn to treatment of a mitochondria-related disease or a condition comprising administering oleuropein, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 to provide improved results.
This is a provisional nonstatutory double patenting rejection.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the teachings of Fowler et al. are applicable to the teachings applied in this nonstatutory double patenting rejection, and are addressed as above.
Amended Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/547,934 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023), further in view of De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023).
The Reference claims of the reference application in view of Fowler et al. teach as above.
The Reference claims in view of Fowler et al. do not specifically teach the method wherein the composition administered further comprises calcium and provides a daily dosage of 0.1 to 1.0 g of the calcium (claim 28).
De Marchi et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 10-11 in view of Fowler et al. further in view of De Marchi et al. in order to select the dosage of the calcium administered. One of ordinary skill in the art would have been motivated to combine Reference claims 10-11 in view of Fowler et al. further in view of De Marchi et al. with a reasonable expectation of success because all of Reference claims 10-11, Fowler et al., and De Marchi et al. are drawn to a similar method of treatment comprising administering oleuropein, and De Marchi et al. teaches the method of treatment comprising administering the combination of oleuropein and calcium and provides guidance for selecting the effective amount of calcium administered.
Amended Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/866,398 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 1-13 of the reference application are drawn to a method for use in including improving a physiological state linked to metabolic fatigue in one or more cells, increasing mitochondrial energy and mitochondrial calcium uptake in one or more cells, and enhancing mitochondrial function, comprising administering to a subject in need of same, a composition comprising a combination of oleuropein and/or a metabolite thereof and fisetin and/or a derivative, in a therapeutically effective amount. Reference claim 2-3 corresponds to the limitations of claim 2-3, respectively. Reference claim 5-6 corresponds to the limitations of claim 4-5, respectively. Reference claim 8-11 corresponds to the limitations of claim 6-9, respectively. Reference claims 12-13 correspond to limitations of claims 10-11.
Reference claims 1-13 do not specifically recite the method comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and Vitamin B6 (claims 1, 10, and 12).
Fowler et al. teaches as above.
It would have been obvious to combine Reference claims 1-12 in view of Fowler et al. in order to combine the method of administering oleuropein of the Reference claims with the combination with vitamin B6 taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1-11 in view of Fowler et al. with a reasonable expectation of success because both the Reference claims and Fowler et al. are drawn to treatment of a mitochondria-related disease or a condition comprising administering oleuropein, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 to provide improved results.
This is a provisional nonstatutory double patenting rejection.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 03 April 2026, have been fully considered and not found to be persuasive.
Applicant’s remarks regarding the teachings of Fowler et al. are applicable to the teachings applied in this nonstatutory double patenting rejection, and are addressed as above.
Amended Claim 28 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/866,398 (reference application) in view of Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023), further in view of De Marchi et al. (WO 2020/229539 A1, published 19 Nov 2020, provided by Applicant in IDS filed 25 Aug 2023).
Reference claims 1-13 of the reference application in view of Fowler et al. teach as above.
Reference claims 1-13 in view of Fowler et al. do not specifically teach the method wherein the composition administered further comprises calcium and provides a daily dosage of 0.1 to 1.0 g of the calcium (claim 28).
De Marchi et al. teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-13 in view of Fowler et al. further in view of De Marchi et al. in order to select the dosage of the calcium administered. One of ordinary skill in the art would have been motivated to combine Reference claims 10-11 in view of Fowler et al. further in view of De Marchi et al. with a reasonable expectation of success because all of Reference claims 1-13, Fowler et al., and De Marchi et al. are drawn to a similar method of treatment comprising administering oleuropein, and De Marchi et al. teaches the method of treatment comprising administering the combination of oleuropein and calcium and provides guidance for selecting the effective amount of calcium administered.
Conclusion
No claim is found to be allowable.
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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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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