DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/25/2023 and 07/02/2025 have been considered by the examiner.
Status of the Claims
The response filed 12/01/2025 is acknowledged.
Claims 1-12 are pending.
Applicant’s election without traverse of Group 1, claims 1-9, in the reply filed on 12/01/2025 is acknowledged.
Applicant’s election without traverse of oleuropein and condition (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, in the reply filed on 12/01/2025 is acknowledged. Applicant indicates claims 1-4 and 6-9 read on the elected species.
Claim 3 appears to be directed to condition (i) rather than condition (iii).
Claims 3, 5 and 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/01/2025.
Claims 1-2, 4 and 6-9 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, and 6-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Mehansho, US 20180042287.
Mehansho teaches compositions comprising magnesium and oleuropein (Mehansho, e.g., 0065, Table 1). Mehansho teaches administering the composition to subjects in need of activating adenosine monophosphate activated protein kinase (AMPK) and signaling pathway stemming therefrom, and in need of reducing oxidative damage and oxidative stress by agents which inhibit the activity of pro-oxidants including reactive oxygen species (Mehansho, e.g., 0056-0059, 0065 and 0072 and 0073). The composition contains antioxidants (Mehansho, e.g., 0105 oleuropein antioxidant activity restrains oxidative stress and stimulates AMPK activity), and the composition enhances production of endogenous antioxidants (Mehansho, e.g., 0073).
Thus, Mehansho teaches practicing the method for increasing antioxidant capacity, reducing oxidative stress, and/or enhancing mitochondrial function as per the elected species.
Applicable to claim 2: the composition activates AMPK which is expressed in the kidney, liver and skeletal muscle (Mehansho, e.g., 0029-0030).
Applicable to claim 6: Mehansho teaches the composition further comprising vitamins and minerals (Mehansho, e.g., claim 14).
Applicable to claims 7-9: Mehansho teaches the composition in the form of powders, drink mixes, capsule, and beverages, e.g., liquid solution (Mehansho, e.g., 0020 and claim 17). Mehansho teaches the composition as a food product, food composition, dietary supplement, nutritional supplement, wherein the composition optionally contains proteins, carbohydrates, fats, vitamins, minerals (Mehansho, e.g., 0016-0023).
Mehansho anticipates the subject matter of instant claims 1-2, and 6-9.
Claims 1-2, 4, 6-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rey, Animals, 2021.
Rey teaches methods comprising administering a composition comprising oleuropein and magnesium for improved antioxidant and metabolic effects (Rey, entire document, e.g., pg. 1/15 simple summary and pg. 13/15 conclusions). The limitations of increasing antioxidant capacity and reducing antioxidant stress read on these effects. Rey notes improved muscle lipid stability and oxidative status (Rey, entire document, e.g., pg. 13/15, conclusions).
Applicable to claim 4, the combination comprising oleuropein and magnesium is administered daily for 34 days which is at least a week (Rey, e.g., pg. 3/15).
Applicable to claims 6 and 7 and 9, the combination is administered as a food composition further comprising macronutrients including calcium, protein, carbohydrate, and fat (Rey, entire document, e.g., pg. 3/15, e.g., table 1). The combination comprising oleuropein and magnesium further comprises antioxidants, e.g., vitamin e, betaine (Rey, entire document, e.g., pg. 1/15, simple summary).
Rey notes oleuropein and magnesium are antioxidant agents (Rey, entire document, e.g., pg. 10/15, ¶ 1). Thus, the practice of Rey’s method will naturally increase antioxidant capacity to the extent that consumption of antioxidant agents necessarily increases antioxidant capacity due to increased amounts of antioxidant agents present after consumption.
Rey anticipates the subject matter of instant claims 1-2, 4, 6-7, and 9.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mehansho, US 20180042287 in view of De Groote, US 20120009276.
The teachings of Mehansho enumerated above teach a method according to claim 1, wherein the composition may be administered by oral route daily (Mehansho, e.g., 0125). Mehansho does not expressly teach administering daily for at least a week.
However, De Groote teaches methods for treating oxidative stress (De Groote, e.g., 0004 and 0023), wherein the method is practiced by administering as long as required, e.g., weeks, months or years, to see an improvement in oxidative stress (De Groote, e.g., 0073).
It would have been obvious before the effective filing date of the presently claimed invention to practice a method for treating oxidative stress and antioxidant supplementation comprising administering a composition comprising oleuropein and magnesium as understood from Mehansho by administering the composition daily through an oral route and administering the composition for as long as required to see an improvement in oxidative stress parameters as suggested by De Groote. The skilled artisan would have optimized Mehansho’s method by adjusting the duration of administration within the time frames suggested by De Groote to manage oxidative stress as desired by Mehansho with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-2, 4, and 6-9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-2, 4, and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-13 of US 18866398 in view of Mehansho, US 20180042287.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach methods for increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof in a therapeutically effective amount.
The reference claims do not expressly teach wherein the composition comprises magnesium. However, this defect is cured by the teachings of Mehansho enumerated above.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of the reference claims by including an effective amount of magnesium with a reasonable expectation of success. Since Mehansho teaches magnesium reduces oxidative stress in combination with oleuropein, the skilled artisan would have been motivated to include magnesium in the composition of the reference claim’s method with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-2, 4, and 6-9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-2, 4, and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-12 of US 18547932 in view of Mehansho, US 20180042287.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach methods for increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof in a therapeutically effective amount.
The reference claims do not expressly teach wherein the composition comprises magnesium. However, this defect is cured by the teachings of Mehansho enumerated above.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of the reference claims by including an effective amount of magnesium with a reasonable expectation of success. Since Mehansho teaches magnesium reduces oxidative stress in combination with oleuropein, the skilled artisan would have been motivated to include magnesium in the composition of the reference claim’s method with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-2, 4, and 6-9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-2, 4, and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-11 of US 18253428 in view of Mehansho, US 20180042287.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach methods for increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof in a therapeutically effective amount.
The reference claims do not expressly teach wherein the composition comprises magnesium. However, this defect is cured by the teachings of Mehansho enumerated above.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of the reference claims by including an effective amount of magnesium with a reasonable expectation of success. Since Mehansho teaches magnesium reduces oxidative stress in combination with oleuropein, the skilled artisan would have been motivated to include magnesium in the composition of the reference claim’s method with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-2, 4, and 6-9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 1-2, 4, and 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-13 of US 18253419 in view of Mehansho, US 20180042287.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach methods for increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, comprising administering to the individual a composition comprising a combination of oleuropein and/or a metabolite thereof and quercetin and/or a derivative, in a therapeutically effective amount.
The reference claims do not expressly teach wherein the composition comprises magnesium. However, this defect is cured by the teachings of Mehansho enumerated above.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method of the reference claims by including an effective amount of magnesium with a reasonable expectation of success. Since Mehansho teaches magnesium reduces oxidative stress in combination with oleuropein, the skilled artisan would have been motivated to include magnesium in the composition of the reference claim’s method with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-2, 4, and 6-9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615