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 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 are pending in the current application and are examined on the merits herein.
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.
Claim 5 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 5 recites “the metabolite of oleuropein is selected from the group consisting of consisting of oleuropein aglycone, hydroxytyrosol, elenolic acid, homovanillyl alcohol, isohomovanillyl alcohol, glucuronidated forms thereof, sulfated forms thereof, derivatives thereof, and mixtures thereof.” (emphasis added) The recitation of “derivatives thereof” renders the claim indefinite because it is unclear what compounds are considered to be “derivatives” of any of the recited compounds, such as to what extent a compound may be modified and still be considered a “derivative”, the specification does not define the scope of these “derivatives”, and it is unclear what the scope of the claim is. For example, it is unclear whether or not water is considered to be a “derivative” of any of the recited compounds. The specification does not define what the scope of “derivative” encompasses, therefore the claim failing to particularly point out and distinctly claim the subject matter because as stated above it is unclear what compounds are considered to be “derivatives”.
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.
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).
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). 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 addressing limitations of claims 10-11. Fowler et al. discloses the effective dosage of each of hydroxytyrosol and vitamin B6 in their invention (page 7, paragraphs 110-112 and 126). 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. does not explicitly disclose the specific embodiment of the method comprising administering the combination of the oleuropein metabolite hydroxytyrosol and vitamin B6. However, Fowler et al. states that the invention intended to include each single combination of hyroxytyrosol with each of the individual compounds within the group, and provides additional guidance in the narrower disclosure of the hydroxytyrosol is used in combination at least one of the compounds selected from the group consisting of caffeine, carnitine, and a B Vitamin. In the context of this specific disclosure and the particular products at issue, a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination of the method comprising administering the combination of the oleuropein metabolite hydroxytyrosol and vitamin B6 based on this disclosure of Fowler et al.
Therefore the disclosure of Fowler et al. taken as a whole would lead one of skill in the art to ‘at once envisage’ the claimed method of claims 1-12 as discussed above.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over De Fowler et al. (US 2012/0225840, published 06 Sep 2012, provided by Applicant in IDS filed 25 Aug 2023).
Fowler et al. discloses as above. 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).
Fowler et al. disclose specifically disclose the method comprising administering the combination of the oleuropein and vitamin B6 (claim 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 select from within the scope of Fowler et al. in order to pick and choose the method of administering oleuropein instead of or in addition to hydroxytyrosol in the combination of Fowler et al. One of ordinary skill in the art would have been motivated to modify the teachings of Fowler et al. with a reasonable expectation of success because Fowler et al. teaches hydroxytyrosol derivatives such as esters and physiologically or pharmaceutically acceptable salts may be used instead of or in addition to hydroxytyrosol, and the most preferred ester of hydroxytyrosol is oleuropein.
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).
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. 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), addressing limitations of claims 1, 10, and 12. 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.
De Marchi et al. does not specifically disclose the embodiment comprising administering a combination of composition comprising a combination of oleuropein and/or a metabolite thereof and 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 select from within the scope of De Marchi et al. in a manner that arrives at the claimed invention. One of ordinary skill in the art would have been motivated to select from within the teachings of De Marchi et al. with a reasonable expectation of success because De Marchi et al. teaches embodiments in which the composition comprises vitamins which can include vitamin B6. Further, De Marchi et al. teaches the method in which the combination of calcium and at least one of oleuropein or metabolite thereof and further including vitamins such as vitamin B6 is administered in an amount such the combination as a whole is therapeutically effective.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 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 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 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.
Claims 1-12 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 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.
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).
Reference claims 1, 3-4, 6-10, 16-17, and 20-21 of the reference application are drawn to a method of decreasing muscle fatigue in an individual who participates in exercise, comprising orally administering to the individual an effective amount of a combination of calcium and at least one of oleuropein or metabolite thereof, wherein the at least one of oleuropein or metabolite thereof is selected from the group consisting of oleuropein, oleuropein aglycone, homovanillyl alcohol, isohomovanillyl alcohol and mixtures thereof. Reference claim 6 recites the composition in the form of a food product, corresponding to claim 7. Reference claim 9 recite the components of the food product, corresponding to claim 9.
Reference claims 1, 3-4, 6-10, 16-17, and 20-21 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, 3-4, 6-10, 16-17, and 20-21 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, 3-4, 6-10, 16-17, and 20-21 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.
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).
Reference claims 1, 3-6, 17, and 19-24 of the reference application are drawn to a method for improving resistance to muscle fatigue from exercise in an individual in need thereof, comprising orally administering to the individual an effective amount of a combination of calcium and at least one of oleuropein or metabolite thereof, wherein the at least one of oleuropein or metabolite thereof is selected from the group consisting of oleuropein, oleuropein aglycone, homovanillyl alcohol, isohomovanillyl alcohol and mixtures thereof. Reference claim 3 recites the composition in the form of a food product, corresponding to claim 7. Reference claim 5 recite the components of the food product, corresponding to claim 9. Reference claim 7 is drawn to a unit dosage form comprising the oleuropein for the intended use of administration for the same results as the claimed method, making obvious this method of using the claimed unit dosage form.
Reference claims 1, 3-7, 17, and 19-24 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, 3-7, 17, and 19-24 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, 3-7, 17, and 19-24 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.
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).
Reference claims 1-10, 13, and 15-19 of the reference application are drawn to a method for treating sarcopenia and/or physical frailty, and/or for -improving skeletal muscle mass, skeletal muscle lean mass, skeletal muscle strength and/or skeletal muscle function in an individual in need thereof, the method comprising administering to the individual a therapeutically effective amount of a composition comprising a combination of Vitamin B6 and Nicotinamide. Reference claims 7-8 recites the composition in the form of a food product, corresponding to claims 7-8 respectively. Reference claim 13 recites the components of the food product, corresponding to claim 9.
Reference claims 1-10, 13, and 15-19 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. Fowler et al. further teaches the combination of hydroxytyrosol with vitamin B3 or niacinamide (abstract; page 2, paragraph 14). Niacinamide is known to be a form of vitamin B3, and is synonymous with nicotinamide.
It would have been obvious to combine Reference claims 1, 3-7, 17, and 19-24 in view of Fowler et al. in order to combine the method of administering Vitamin B6 and Nicotinamide of the Reference claims with the combination with hydroxytyrosol or oleuropein taught by Fowler et al. One of ordinary skill in the art would have been motivated to combine Reference claims 1, 3-7, 17, and 19-24 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 Vitamin B6 in an effective amount, and Fowler et al. teaches the improvement of administering the oleuropein in combination with vitamin B6 or Nicotinamide to provide improved results.
This is a provisional nonstatutory double patenting rejection.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 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 1-11 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 1-11 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 combine Reference claims 1-11 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.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/547,934 (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.
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).
Reference claims 1-6 of the reference application are drawn to a method of preventing or treating muscle fatigue from exercise and/or for resistance to muscle fatigue from exercise, the method comprising orally administering an effective amount of at least one of oleuropein or metabolite thereof to an individual. Reference claim 2-5 corresponds to the limitations of claim 2-5, respectively. Reference claim 3 recites the composition in the form of a food product, corresponding to claim 7. Reference claim 5 recites the components of the food product, corresponding to claim 9.
Reference claims 1-6 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 1-6 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 1-6 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 muscle fatigue 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.
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).
Reference claims 1-12 of the reference application are drawn to a method resulting in a group including improved mitochondrial calcium uptake in muscle cells, increased mitochondrial energy in muscle cells, improvement in at least one of muscle functionality, muscle performance, lean muscle mass or muscle strength, and decreased muscle fatigue, comprising administering to a subject in need of same, a composition comprising a combination of oleuropein and/or a metabolite thereof and creatine, in a therapeutically effective amount. Reference claim 6 corresponds to limitations of claim 4. Reference claim 7 corresponds to claim 5. Reference claim 8 corresponds to claim 7. Reference claim 11 corresponds to limitations of claim 9.
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. Fowler et al. further teaches the combination of hydroxytyrosol with creatine (abstract; page 2, paragraph 14).
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 and creatine 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 1-12 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 resulting in increased mitochondrial energy in muscle cells or decreased muscle fatigue comprising administering oleuropein and creatine, 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.
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.
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).
Reference claims 1-12 of the reference application are drawn to a method for use in including improved mitochondrial calcium uptake in muscle cells, increased mitochondrial energy in muscle cells, improvement in at least one of muscle functionality, muscle performance, or muscle strength, and decreased muscle fatigue, comprising administering to a subject in need of same, a composition comprising a combination of oleuropein and/or a metabolite thereof and caffeine, in a therapeutically effective amount. Reference claim 6-7 corresponds to the limitations of claim 4-5, respectively. Reference claim 8 corresponds to the limitations of claim 7. Reference claim 11 corresponds to the limitations of claim 9, 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. Fowler et al. further teaches the combination of hydroxytyrosol with caffeine (abstract; page 2, paragraph 14).
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 and caffeine 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 1-12 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 resulting in increased mitochondrial energy in muscle cells or decreased muscle fatigue comprising administering oleuropein and caffeine, 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.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693