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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-13, 18, 22-23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a composition comprising a unit dosage of calcium and at least one oleuropein or metabolite thereof selected from oleuropein aglycone, homovanillyl alcohol, and isohomovanillyl alcohol.
Claim 11 recites several composition types that implicitly include other ingredients and the claim also recites that the composition consists essentially of the combination of calcium and at least one oleuropein or metabolite thereof. The “consisting essentially of” language excludes additional compounds that affect mitochondrial calcium import (see instant specification paragraph 39). Calcium is a naturally occurring mineral. In addition, olives are taught to be rich in calcium and to be a source of oleuropein and its metabolites, where these compounds are also present in olive oil (see Guo et al. – previously cited - page 1096 second column table 2, tables 4-5). Metabolites found in the olive plant include oleuropein aglycone and homovanillyl alcohol (see Guo et al. tables 4 and 5). Thus the claimed composition is directed toward a combination of natural ingredients which makes it a product of nature.
While the disclosure discusses a synergistic interaction between calcium and oleuropein in histamine stimulated HeLa cells with 1.5 mM calcium and 10 mM oleuropein, there is no evidence that this synergy is absent when calcium and oleuropein are present in combination without the companion compounds otherwise present in olives or olive oil that affect mitochondrial calcium import. It additionally is not evident that synergistic behavior is uniquely at the tested concentrations or that it would extend to the other claimed metabolites of oleuropein. There is no indication of calcium physically or chemically interacting with the oleuropein or oleuropein metabolites upon extraction from the olive that would alter their behavior or structure or vice versa. Thus calcium in combination with oleuropein and in combination with the claimed metabolites of oleuropein are not markedly different from and do not amount to significantly more than the natural ingredients themselves. This judicial exception is not integrated into a practical application because the claims do not apply the natural product.
The claims do not require additional elements that are sufficient to amount to significantly more than the judicial exception because they recite composition forms that do not require additional elements (e.g., dietary supplement, nutraceutical, food additive, etc.). Some component forms require additional elements, but several of them can also be natural such as milk or water to yield a beverage and do not yield significantly more than a natural product. The claim also recites “unit dosage form” and the presence of the natural components at issue in an amount effective for decreasing muscle fatigue in an individual who participates in at least one of three varieties of exercise, neither of which requires additional elements. Further, claim 25 recites whey protein isolate as an additional ingredient. Whey protein is a naturally occurring part of milk (see Gupta et al. Beverages 2017 3(31):1-14, page 1). There is no indication that its purification from milk and inclusion with calcium in combination with oleuropein or its recited metabolites confers any different structure or function to the combination Therefore the claims embrace subject matter that is not patent eligible.
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, 3, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Musumeci et al. (previously cited) in view of Landeka et al. (previously cited) and Feng et al. (previously cited) as evidenced by Guo et al. and Kouka et al. (previously cited).
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by administering extra virgin olive oil to rats fed an otherwise standard diet (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The diet included protein, carbohydrate, a mineral mixture and a vitamin mixture along with lipids, where the treated rats had extra virgin olive oil as the lipids in their feed (see page 62 second column first full paragraph; instant claims 1, 7, and 14-15). Musumeci et al. go on to detail that extra virgin olive oil contains oleuropein and hydroxytyrosol and is minimally processed so as to avoid physically alter the oil (see page 62 first column first full paragraph and second column last partial paragraph-page 63 first column first full paragraph ; instant claims 1, 5 and 14). In addition to containing these compounds, olive oil also contains calcium (see Guo et al. page 1096 second column table 2, tables 4-5). Skeletal muscle tissue of the exercised rats showed extensive damage that was not present in the extra virgin olive oil fed subjects or in sedentary subjects (see figure 1 and page 64 second column last partial paragraph). In addition, Musumeci et al. detail that oxidative stress of the extra virgin olive oil fed exercised subjects was similar to that of the sedentary subjects and significantly lower than that of the untreated exercised subjects (see table 3, page 66 first column second-third full paragraphs, and page 67 second column). Kouka et al. teach that oxidative stress in muscle tissue results in muscle fatigue, thus the outcome of extra virgin olive oil treatment by Musumeci et al. is a reduction/inhibition of muscle fatigue (see page 704 first column first-second paragraph; instant claims 1 and 10). The full composition of the standard feed given to the subjects is not detailed.
Landeka et al. teach the administration of a standard diet to rats (see abstract and page 64 first column second full paragraph). The feed is listed as containing several minerals and vitamins, proteins fats, carbohydrates, where they elaborate on the particular components and list multiple forms of calcium, a mineral, as constituents (see abstract and page 64 first column second full paragraph). They additionally teach administering olive oil as a separate composition to the rats orally (see page 63 second column last paragraph and page 64 first column last partial paragraph).
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of the oleuropein metabolite hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph; instant claims 1 and 3). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph; instant claim 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the mineral combination and vitamin combination of Landeka et al. as the mineral mixture and vitamin mixture in the feed employed by Musumeci et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g. specific vitamin/mineral mixture vs. generic vitamin/mineral mixture). The administration as supplemented feed and/or as a separate olive oil supplement would have been obvious, given that both routes are employed for gleaning the benefits of orally administered olive oil. The result would be the administration of calcium (via the olive oil and/or the feed), oleuropein, and hydroxytyrosol to the rat subjects in one composition where vitamins and minerals are also present along with protein, carbohydrate, and fat in a food composition (see instant claims 1 and 6). It additionally would have been obvious to perform the administration less than one hour before endurance/exhaustive exercise because Feng et al. teach of the effectiveness of this timing to administering for oleuropein metabolites to impact the same body system envisioned by Musumeci et al. in a similar way. Therefore claims 1, 3, 6-7, and 10 are obvious over Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al.
Claims 1, 3, 6-7, 10, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. as applied to claims 1, 3, 6-7, and 10 above, and further in view of Barbaro et al. (previously cited) as evidenced by the Extra Virgin Olive Oil Safety Data Sheet (previously cited).
Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. render obvious the limitations of instant claims 1, 6-7, and 10. The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph). This oil is present at 28.5 g/100g feed (see table 1). The oleuropein proportion is not detailed.
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a known (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. in the feed of Musumeci et al. and the resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 10, and 16-17 are obvious over Musumeci et al. in view of Landeka et al., Feng et al., and Barbaro et al. as evidenced by Gou et al., Kouka et al., and the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 3-4, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. as applied to claims 1, 3, 6-7, and 10 above, and as further evidenced Kohn et al. (previously cited) and Nijhuis et al. (previously cited).
Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. render obvious the limitations of instant claims 1, 3, 6-7, and 10. Musumeci et al. assess the impact of the treatment on the Quadriceps femoris muscle group (see page 63 first column third full paragraph). This muscle group includes the Vastus lateralis, Vastus medialis, Vastus intermedius and Rectus femoris (see Kohn et al. page 9 first column first full paragraph). Nihjuis et al. teach that the Biceps femoris is located in the same leg region and nearly adjacent to the Vastus lateralis (see figure 2). As a result, the artisan of ordinary skill would expect a similar impact (e.g., fatigue reduction) in the Biceps femoris as seen in the Quadricep femoris. Therefore claims 1, 3-4, 6-7, and 10 are obvious over Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al., Kohn et al., and Nihjuis et al.
Claims 1, 3, 6-7, 10, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. as applied to claims 1, 3, 6-7, and 10 above, and further in view of Toyomura et al. (previously cited) and Rosenberg (US Patent No. 5,601,760)
Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. render obvious the limitations of instant claims 1, 6-7, and 10 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by Musumeci et al. in view of Landeka et al. and Feng et al. as evidenced by Gou et al. and Kouka et al. because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3, 6-7, 10, and 24 are obvious over Musumeci et al. in view of Landeka et al., Feng et al., Toyomura et al., and Rosenberg as evidenced by Gou et al., and Kouka et al.
Claims 11, 13-15, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (previously cited).
Hall et al. teach a nutritional composition (nutraceutical) composed of oleuropein and cyclodextrin that is also taught and exemplified with calcium (see page 9 last partial paragraph and following table, claims 1 and 6). Glycerol esters are additionally taught to facility integration of the oleuropein into the cyclodextrin to alleviate the bitterness of the oleuropein for oral consumption (see page 8). The composition is envisioned to provide oleuropein due to its various biological and therapeutic effects and is noted to primarily originate from olives and the olive plant (see pages 1-2). Claim 6 of Hall et al. detail 4 options for an additional component, one of which yields a mixture of oleuropein, calcium, and cyclodextrin where excipients, such as the carbohydrate sweetener xylitol, may be included as well (see claim 6). The composition is recited to include 0.1 to 1000 mg oleuropein and 2 to 3500 mg calcium which can be viewed as a unit dose and may also be provided as a liquid (see paragraphs page 9 last partial paragraph). These values are embraced by or overlap the instant disclosure of effective amounts of each (see paragraphs page 9 last partial paragraph and following table; instant specification paragraphs 72-73; instant claims 11 and 13-14). While a full example of each embodiment that follows from teachings of Hall et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare their nutritional composition with just cyclodextrin, calcium, and oleuropein that optionally also includes xylitol and glycerol ester. These choices would have been obvious because Hall et al. explicitly recite them amongst a narrow set of options and exemplify their combination. The xylitol meets the limitation of a carbohydrate and the glycerol ester is an excipient (see instant claims 14-15). The quantities of calcium and oleuropein detailed by Hall et al. overlap or meet those instantly recited as an effective amount to reduce or treat muscle fatigue, thereby rendering them obvious. “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)” (see MPEP 2144.05). Therefore claims 11, 13-15, and 22-23 are obvious over Hall et al.
Claims 11, 13-15, 22-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. as applied to claims 11, 13-15, and 22-23 above, and further in view of Pal et al. (British Journal of Nutrition 2010 104:716-72).
Hall et al. render obvious the limitations of instant claims 11, 13-15, and 22-23, where oleuropein and calcium in an oral composition devoid of additional polyphenols is provided. Hall et al. detail the utility of oleuropein to promote insulin release and glycemic control (see page 2 second full paragraph). The presence of whey protein isolate is not detailed.
Pal et al. teach that orally administered whey protein isolate improved insulin sensitivity in human subjects (see abstract and page 721 second column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add whey protein isolate to the composition of Hall et al. as an additional glycemic control active. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06). Therefore claims 11, 13-15, 22-23 and 25 are obvious over Hall et al. in view of Pal et al.
Claims 1, 3, 6-7, 10-11, 13-15, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. as applied to claims 11, 13-15, and 22-23 above, and further in view of Rietjens et al. (previously cited) and Toyomura et al.
Hall et al. render obvious the limitations of instant claims 11, 13-15, and 22-23, where oleuropein and calcium in a composition devoid of additional polyphenols is provided. Administration to a subject within 2 hours of or during exercise is not detailed.
Rietjens et al. teach the administration of olive extract for muscle health in animals prone to muscle pain and soreness (fatigue) due to exercise to permit a longer duration and greater intensity of exercise (see abstract and page 2 lines 5-25). They additionally teach administration prior to, during, or shortly after the exercise (see page 2 lines 19-25). An example provides the extract 30 minutes before resistance exercise (see page 10 lines 13-27).
Toyomura et al. teach that the dietary administration of the oleuropein improved exercise endurance (e.g., reduced muscle fatigue) by 20% as part of a composition intended to reduce fatigue due to exercise (see paragraph 33 and table 1 ‘None’ sample vs ‘oleuropein’ sample ‘without chicken extract’ embodiments). The administered solution includes 10 mg/ml oleuropein (see paragraph 78). They also teach 667 mg of oleuropein loaded into an oral capsule as an exemplary dosage form (see paragraph 98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the compositions rendered obvious by Hall et al. to a subject thirty minutes prior to or during resistance or endurance exercise. This choice would have been obvious in light of Toyomura et al. who teach of the improvement oleuropein can provide to endurance and Rietjens et al. who teach this timing of administering olive extracts to reduce muscle soreness (fatigue) and permit better exercise endurance. Therefore claims 1, 3, 6-7, 10-11, 13-15, and 20-23 are obvious over Hall et al. in view of Rietjens et al. and Toyomura et al.
Claims 11, 13-15, 18-21, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. as applied to claims 11, 13-15, and 22-23 above, and further in view of Lee-Huang et al. (previously cited).
Hall et al. render obvious the limitations of instant claims 11,13-15, and 22-23, where oleuropein and calcium in a composition devoid of additional polyphenols is provided for improves oleuropein palatability. The instantly claimed composition is not explicitly taught.
Lee-Huang et al. teach various concentrations of oleuropein provided in drinking water (see paragraph 349). Here a concentration of 5 mg/ml is detailed (see pragaph 349). Such a solution corresponds to a molar concentration of solution 9.25mM (as calculated by the examiner given a 540 molar mass of oleuropein).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the composition of Hall et al as the oleuropein source because of its ability to remove the bitterness associated with the compound and improve its palatability. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The result is a composition with cyclodextrin, calcium, and oleuropein at a concentration very near that instantly claimed. Given the absence of any evidence of an unexpectedly superior result for the claimed oleuropein concentration at all calcium concentrations, the obviousness of routine experimentation by the artisan to select a concentration that achieves the desired dosing renders the claimed concentrations obvious. Therefore claims 11, 13-15, 18-21, and 22-23 are obvious over Hall et al. in view of Lee-Huang et al.
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.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 11 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-16 of copending Application No. 18/862394 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating or reducing muscle fatigue due to exercise in an individual induced by at least one of 1) resistance exercise, 2) anaerobic or repeated sprint-type exercise, or 3) endurance exercise by orally administering a composition of oleuropein or a metabolite thereof to the individual. Both sets of claims also include calcium as an ingredient as well as name the same oleuropein metabolite options. No additional components are required. The process of making the composition is also recited by both sets of claims. The copending claims detail many of the same final forms of the composition as well as protein, carbohydrates, and fat as components/excipients to include. While a single lineage of claims does not meet each instant claim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the methods of the instant claims, where calcium is included in the composition, based upon the recited additional components and component configurations of the copending claims. The composition additionally can comprise a unit dose (or more) in the claimed final forms. Therefore claims 11 and 13-15 are obvious over claims 1-6 and 13-16 of copending Application No. 18/862394.
Claims 11, 13-15, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-16 of copending Application No. 18/862394 as applied to claims 11 and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1-6 and 13-16 of copending Application No. 18/862394 render obvious the limitations of instant claims 11 and 13-15 in an oral composition with oleuropein and calcium for reducing muscle fatigue due to exercise. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 11, 13-15, and 25 are obvious over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Toyomura et al. and Rosenberg.
Claims 1, 3, 6-7, 10-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-16 of copending Application No. 18/862394 as applied to claims 11 and 13-15 above, and further in view of Feng et al.
Claims 1-6 and 13-16 of copending Application No. 18/862394 render obvious the limitations of instant claims 11 and 13-15, where a composition with the instantly claimed components is administered to the instantly claimed population to treat muscle fatigue. The time of administration relative to exercise is not detailed nor is a particular claimed muscle recited in which the fatigue is reduced or inhibited.
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph). The hydroxytyrosol is provided as an olive extract and naturally found in olive oil (see page 1438 first column second full paragraph and second column first partial paragraph). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the composition of the method of copending claims less than one hour before exercise because such actives were shown to be effective against muscle fatigue via this administration regimen as taught by Feng et al. It also would have been obvious to expect or produce a reduction in incidence of intensity of muscle fatigue in the soleus muscle in the method of the copending claims as also detailed by Feng et al. because the same active is being administered for the same purpose and a similar outcome would be desirable. Therefore claims 1, 3, 6-7, 10-11, and 13-15 are obvious over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al.
Claims 1, 3, 6-7, 10-11, 13-15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al. as applied to claims 1, 3, 6-7, 10-11, and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al. render obvious the limitations of instant claims 1, 3, 6-7, 10-11, and 13-15 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the modified copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3, 6-7, 10-11, 13-15, and 24-25 are obvious over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al., Toyomura et al., and Rosenberg.
Claims 1, 3, 6-7, 10-11, and 13-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al. as applied to claims 1, 3, 6-7, 10-11, and 13-15 above, and further in view of Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1-6 and 13-16 of copending Application No. 18/862394 render obvious the limitations of instant claims 1, 3, 6-7, 10-11, and 13-15. A concentration for the oleuropein that is administered is not detailed.
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by orally administering extra virgin olive oil (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph).
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. as an oral oleuropein source for the method of the copending claims in light of Musumeci et al. This choice would have bene obvious because the olive oil is a known source indicated as suitable for a similar use detailed by the method of the copending claims. The resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 10-11, and 13-17 are obvious over claims 1-6 and 13-16 of copending Application No. 18/862394 in view of Feng et al., Musumeci et al., and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 11 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating or reducing muscle fatigue due to exercise in an individual induced by at least one of 1) resistance exercise, 2) anaerobic or repeated sprint-type exercise, or 3) endurance exercise by orally administering a composition of oleuropein or a metabolite thereof to the individual. Both sets of claims also include calcium as an ingredient as well as name the same oleuropein metabolite options. Other components are not required. The process of making the composition is also recited by both sets of claims. The copending claims detail many of the same final forms of the composition as well as protein, carbohydrates, and fat as components/excipients to include. They also detail the same muscles being impacted. Further, a unit dosage form of the composition is also recited by both sets of claims as well as a composition consisting essentially of the calcium and oleuropein. While a single lineage of claims does not meet each instant claim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the methods of the instant claims, where calcium is included in the composition, based upon the recited additional components and component configurations of the copending claims. Therefore claims 11 and 13-15 are obvious over claims 1-7, 13-17, and 19 of copending Application No. 17/736496.
Claims 11, 13-15, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 as applied to claims 11 and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1-7, 13-17, and 19 of copending Application No. 17/736496 render obvious the limitations of instant claims 11 and 13-15 in an oral composition with oleuropein and calcium for reducing muscle fatigue due to exercise. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 11, 13-15, and 25 are obvious over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Toyomura et al. and Rosenberg.
Claims 1, 3-4, 6-7, 10-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 13-16 of copending Application No. 17/736496 as applied to claims 1, 5-7, and 9-15 above, and further in view of Feng et al.
Claims 1-7, 13-17, and 19 of copending Application No. 17/736496 render obvious the limitations of instant claims 11 and 13-15where a composition with the instantly claimed components is administered to the instantly claimed population to treat muscle fatigue. The time of administration relative to exercise is not detailed.
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph). The hydroxytyrosol is provided as an olive extract and naturally found in olive oil (see page 1438 first column second full paragraph and second column first partial paragraph). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the composition of the method of copending claims less than one hour before exercise because such actives were shown to be effective against muscle fatigue via this administration regimen as taught by Feng et al. Therefore claims 1, 3-4, 6-7, 10-11, and 13-15 are obvious over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al.
Claims 1, 3, 6-7, 10-11, 13-15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al. as applied to claims 1, 3, 6-7, 10-11, and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al. render obvious the limitations of instant claims 1, 3, 6-7, 10-11, and 13-15 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the modified copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3, 6-7, 10-11, 13-15, and 24-25 are obvious over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al., Toyomura et al., and Rosenberg.
Claims 1, 3-4, 6-7, 10-11, and 13-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al. as applied to claims 1, 3-4, 6-7, 10-11, and 13-15 above, and further in view of Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1-7, 13-17, and 19 of copending Application No. 17/736496 render obvious the limitations of instant claims 1, 3-4, 6-7, 10-11, and 13-15. A concentration for the oleuropein that is administered is not detailed.
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by orally administering extra virgin olive oil (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph).
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. as an oral oleuropein source for the method of the copending claims in light of Musumeci et al. This choice would have bene obvious because the olive oil is a known source indicated as suitable for a similar use detailed by the method of the copending claims. The resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3-4, 6-7, 10-11, and 13-17 are obvious over claims 1-7, 13-17, and 19 of copending Application No. 17/736496 in view of Feng et al., Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 3-4, 6-7, 9-10, and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of copending Application No. 17/595166 (reference application) in view of Feng et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating/improving muscle fatigue in skeletal muscle by orally administering a composition of oleuropein or a metabolite thereof to the individual. Both sets of claims also include calcium as an ingredient as well as name the same oleuropein metabolite options. The copending claims detail the same final forms of the composition as well as protein, carbohydrates, and fat as components/excipients to include. Exercise is not detailed as the source of the fatigue in the treated population of the copending claims.
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph). The hydroxytyrosol is provided as an olive extract and naturally found in olive oil (see page 1438 first column second full paragraph and second column first partial paragraph). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the methods of the instant claims, where calcium is included in the composition, based upon the recited additional components and component configurations of the copending claims. The administration of these compositions implicitly require their production (see instant claims 14-15). In addition, it also would have been obvious to practice the method on a subject less than one hour before endurance exercise because such actives were shown to be effective against muscle fatigue via this administration regimen for this variety of skeleton muscle fatigue as taught by Feng et al. It also would have been obvious to expect or produce a reduction in incidence of intensity of muscle fatigue in the soleus muscle in the method of the copending claims as also detailed by Feng et al. because the same active is being administered for the same purpose and a similar outcome would be desirable. Therefore claims 1, 3-4, 6-7, 9-10, and 14-15 are obvious over 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al.
Claims 1, 3-4, 6-7, 9-10, 14-15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. as applied to claims 1, 3-4, 6-7, 9-10, and 14-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. render obvious the limitations of instant claims 1, 3-4, 6-7, 9-10, and 14-15 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the modified copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3-4, 6-7, 9-10, 14-15, and 24-25 are obvious over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al., Toyomura et al., and Rosenberg.
Claims 1, 3-4, 6-7, 10-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. as applied to claims 1, 3-4, 6-7, 9-10, and 14-15 above, and further in view of Masquelier (previously cited).
Claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. render obvious the limitations of instant claims 1, 3-4, 6-7, 9-10, and 14-15 where calcium and oleuropein or a metabolite thereof are included, optionally with excipients, in the administered composition. While a medicament form is recited by the copending claims, the configuration of the composition as a unit dose is not detailed.
Masquelier teaches various units, such as tablets, capsules and ampoules, as known forms for oral administration of a medicament that includes a plant extract (see column 6 lines 22-28). These dosage forms are unit dosage forms.
It would have been obvious to formulate the medicament administered in the method of the modified copending claims as a tablet or capsule in light of Masquelier as known oral dosage forms for an orally administer plant extract. It additionally would have been obvious to include the calcium and oleuropein or a metabolite alone or in combination with inert excipients. Therefore claims 1, 3-4, 6-7, 10-11, and 13-15 are obvious over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. and Masquelier.
Claims 1, 3-4, 6-7, 9-10, and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. as applied to claims 1, 3-4, 6-7, 9-10, and 14-15 above, and further in view of Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. render obvious the limitations of instant claims 1, 3-4, 6-7, 9-10, and 14-15. A concentration for the oleuropein that is administered is not detailed.
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by orally administering extra virgin olive oil (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph).
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. as an oral oleuropein source for the method of the copending claims in light of Musumeci et al. This choice would have bene obvious because the olive oil is a known source indicated as suitable for a similar use detailed by the method of the copending claims. The resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3-4, 6-7, 9-10, and 14-17 are obvious over claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al., Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 6-7, 9-10, and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 (reference application) or claims 1, 3-9, 11-12 copending Application No. 18/866347 (reference application) or claims 1 and 3-12 of copending Application No. 18/866398 (reference application) each separately in view of Coxam et al. and Feng et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating or reducing muscle fatigue due to exercise in an individual induced by at least one of 1) resistance exercise, 2) anaerobic or repeated sprint-type exercise, or 3) endurance exercise by orally administering a composition of oleuropein or a metabolite thereof to the individual. Both sets of claims formulation the composition as a nutritional supplement as well as name the same oleuropein metabolite options. The process of making the composition is implicit in the administration of the composition. The copending claims also detail protein, carbohydrates, and fat as components/excipients to include. The presence of calcium is not explicitly recited in the administered composition.
Coxam et al. teach compositions composed of oleuropein or a metabolite such as hydroxytyrosol formulated as nutritional composition that is envisioned as a variety of forms (see paragraphs 49, 75, and 114). These forms include a cookie or cake (unit dosage) (see paragraph 114). The oleuropein or its metabolite occur in olive fruit and are provided as an extract in the composition (see paragraphs 11 and 20). They go on to teach the inclusion of calcium source in the nutritional composition as an additional nutritional compound (see paragraph 133-134). For food formulations, ingredients necessary to create the baked good beyond the oleuropein or its metabolite and optional other nutritional compound additives constitute excipients
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph). The hydroxytyrosol is provided as an olive extract and naturally found in olive oil (see page 1438 first column second full paragraph and second column first partial paragraph). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of the copending claims where calcium is included as an additional nutritional component in the composition in light of Coxam et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g. additional nutritional supplementation). It additionally would have been obvious to include the calcium and oleuropein or a metabolite alone or in combination with inert excipients the composition, based upon the recited additional components and component configurations of the copending claims. It also would have been obvious to provide the composition of the method of copending claims less than one hour before exercise because such actives were shown to be effective against muscle fatigue via this administration regimen as taught by Feng et al. Therefore claims 1, 3-4, 6-7, 9-10 and 14-15 are obvious over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al.
Claims 1, 3-4, 6-7, 9-10, 14-15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al. as applied to claims 1, 3, 6-7, 10-11, and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al. render obvious the limitations of instant claims 1, 3-4, 6-7, 9-10 and 14-15 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the modified copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3-4, 6-7, 9-10, 14-15, and 24-25 are obvious over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al., Feng et al., Toyomura et al., and Rosenberg.
Claims 1, 3-4, 6-7, 9-10 and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al. as applied to claims 1, 6-7, 9-10, and 14-15 above, and further in view of Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al. render obvious the limitations of instant claims 1, 5-7, 9-10, and 14-15. A concentration for the oleuropein that is administered is not detailed.
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by orally administering extra virgin olive oil (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph).
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. as an oral oleuropein source for the method of the copending claims in light of Musumeci et al. This choice would have bene obvious because the olive oil is a known source indicated as suitable for a similar use detailed by the method of the copending claims. The resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3-4, 6-7, 9-10 and 14-17 are obvious over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al., Feng et al., Musumeci et al., and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1, 3-4, 6-7, 10-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al. and Feng et al. as applied to claims 1, 6-7, 9-10, and 14-15 above, and further in view of Masquelier (previously cited).
Claims 1, 4, and 6-8 of copending Application No. 17/595166 in view of Feng et al. render obvious the limitations of instant claims 1, 3-4, 6-7, 9-10, and 14-15 where calcium and oleuropein or a metabolite thereof are included, optionally with excipients, in the administered composition. While a medicament form is recited by the copending claims, the configuration of the composition as a unit dose is not detailed.
Masquelier teaches various units, such as tablets, capsules and ampoules, as known forms for oral administration of a medicament that includes a plant extract (see column 6 lines 22-28). These dosage forms are unit dosage forms.
It would have been obvious to formulate the medicament administered in the method of the modified copending claims as a tablet or capsule in light of Masquelier as known oral dosage forms for an orally administer plant extract. It additionally would have been obvious to include the calcium and oleuropein or a metabolite alone or in combination with inert excipients. Therefore claims 1, 3-4, 6-7, 10-11, and 13-15 are obvious over claims 1, 3-9, 11-12, 16-17 of copending Application No. 18/866329 or claims 1, 3-9, 11-12 copending Application No. 18/866347 or claims 1 and 3-12 of copending Application No. 18/866398 each separately in view of Coxam et al., Feng et al., and Masquelier.
Claims 1, 3-4, 6-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/595159 (reference application) in view of Feng et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of treating/improving muscle fatigue in the same varieties of skeletal muscle by orally administering a calcium and oleuropein to the individual. The copending claims detail the same final forms of the composition as well as protein, carbohydrates, and fat as components/excipients to include. A unit dose configured in the same way is recited by both sets of claims as is separate administration of the actives. Exercise is not detailed as the source of the fatigue in the treated population of the copending claims.
Feng et al. teach treating rat subjects who participate in strenuous exercise with a diet of normal rat chow and providing an oral dietary supplement of hydroxytyrosol less than one hour prior to exercise to protect against muscle fatigue and damage (see abstract and page 1438 second column second full paragraph). The hydroxytyrosol is provided as an olive extract and naturally found in olive oil (see page 1438 first column second full paragraph and second column first partial paragraph). They go on to teach examination of the soleus muscle for the impact of the treatment (see page 1439 first column first full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of the copending claims on a subject less than one hour before endurance exercise because such actives were shown to be effective against muscle fatigue via this administration regimen for this variety of skeleton muscle fatigue as taught by Feng et al. Therefore claims 1, 3-4, 6-11, and 13-15 are obvious over claims 1-13 of copending Application No. 17/595159 in view of Feng et al.
Claims 1, 3-4, 6-11, 13-15, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/595159 in view of Feng et al. as applied to claims 1, 3-4, 6-11, and 13-15 above, and further in view of Toyomura et al. and Rosenberg.
Claims 11-13 of copending Application No. 17/595159 in view of Feng et al. render obvious the limitations of instant claims 11, 3-4, 6-11, and 13-15 in a method for reducing muscle fatigue due to exercise by orally administering oleuropein and calcium. They do not explicitly discuss the inclusion of whey protein isolate in the administered diet.
Toyomura et al. teach a food for improving motor function regarding better stamina (reduced fatigue) and recovery from fatigue (see abstract). The food includes active ingredients that improve motor performance, where oleuropein and whey protein are named options, along with carnosine and/or anserine (see abstract and paragraphs 24 and 30).
Rosenberg teaches that whey protein included in foods include whey protein isolate (see column 3 lines 23-41 and column 4 lines 12-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the motor function improving actives of Toyomura et al., specifically whey protein with carnosine and/or anserine, to the feed/composition administered by the modified copending claims because they envision oleuropein amongst their actives and seek a similar end goal of reducing muscle fatigue. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. It also would have been obvious to select whey protein isolate as the whey protein, it light of Rosenberg, because it was a known variety of this protein component. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1, 3-4, 6-11, 13-15, and 24-25 are obvious over claims 1-13 of copending Application No. 17/595159 in view of Feng et al., Toyomura et al., and Rosenberg.
Claims 1, 3-4, 6-11, and 13-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/595159 in view of Feng et al. as applied to claims 1-15 above, and further in view of Musumeci et al. and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Claims 1-13 of copending Application No. 17/595159 in view of Feng et al.
render obvious the limitations of instant claims 1, 3-4, 6-11, and 13-15. A concentration for the oleuropein that is administered is not detailed.
Musumeci et al. teach a method of reducing oxidative stress and muscle damage in exhaustively exercised skeletal (endurance exercise) muscle by orally administering extra virgin olive oil (see abstract and page 62 second column first full paragraph; instant claims 1 and 10). The composition contains extra virgin olive oil that has no physical alterations and contains oleuropein (see page 62 second column last partial paragraph-page 63 first column first partial paragraph).
Barbaro et al. teach oleuropein proportions in various olive parts and extracts (see abstract and table 1). They teach the amount of oleuropein in virgin olive oil to range from about 2 to 11.2 mg/kg (see table 1). The Extra Virgin Olive Oil Safety Data Sheet details that such oils have a density of 0.916 g/ml (see page 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ (extra) virgin olive oil with oleuropein as detailed by Barbaro et al. as an oral oleuropein source for the method of the copending claims in light of Musumeci et al. This choice would have bene obvious because the olive oil is a known source indicated as suitable for a similar use detailed by the method of the copending claims. The resulting composition would then have an oil with oleuropein present at 2 to 11.2 mg/mg in the oil. Given the density of extra virgin olive oil, this range corresponds to the oil in the feed having oleuropein present at a concentration of 3.4 to 19 mM (as calculated by the examiner based on 540 g/mol molecular weight for oleuropein). This rather narrow range embraces the claimed concentration, thereby rendering the claimed concentration obvious, absent evidence of criticality (see MPEP 2144.05). Therefore claims 1, 3-4, 6-11, and 13-17 are obvious over claims 1-13 of copending Application No. 17/595159 in view of Feng et al., Musumeci et al., and Barbaro et al. as evidenced by the Extra Virgin Olive Oil Safety Data Sheet.
Response to Arguments
Applicant's arguments filed February 25, 2026 have been fully considered. In light of the amendment that dd new claims, new grounds of rejection are detailed. The applicant’s arguments are not persuasive.
Regarding rejections under 35 USC 101:
The applicant argues that there is no naturally occurring counterpart to the claimed combination and compares it to claim 2 of Example 2 in the nature based products examples of the 2014 Interim Eligibility Guidance. This example does not align with the fact pattern of the instant claims. Here the claimed composition is more aligned with claim 1 of example 3 in the nature based products examples of the 2014 Interim Eligibility Guidance because calcium, oleuropein and its recited metabolites occur naturally together in olives. Thus the claimed composition is more akin to a purified extract like the purified amazonic acid of claim 1 in example 3. There is no indication that the combination of calcium with oleuropein or its recited metabolites has any characteristics that are different from naturally occurring calcium with oleuropein or its recited metabolites in the olive. In a subsequent argument, the applicant also argues that the claimed combination is not an olive or olive oil, due to the meaning ascribed to “consisting essentially of” in the specification. While true, this distinction does not confer patent eligibility to the claimed composition because the composition can be isolated from an olive. The claim therefore encompasses calcium with oleuropein or its recited metabolites that is structurally and functionally identical to naturally occurring calcium with oleuropein or its recited metabolites.
The applicant notes that a tested combination of calcium and oleuropein was synergistic in regard to mitochondrial calcium uptake, but there is no evidence that this is a different function for this combination than when found in the olive. None of the recited oleuropein metabolites were tested in combination with calcium in assessing synergy. Further, there is no evidence that there is a structural difference in the combination of calcium with oleuropein or its recited metabolites that occurs upon their extraction. Thus the claimed composition is not markedly different from a natural produce and for this reason is not patent eligible.
Regarding rejections under 35 USC 103:
The applicant argues that their showing of unexpected results should be sufficient to overcome any prima facie case of obviousness that exists. As noted in MPEP 716.02(d), “[w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.” Here the method claimed recites decreasing muscle fatigue in an individual who participates in exercise by orally administering this subject an effective combination of calcium with oleuropein or a metabolite thereof. The showing was provided at one concentration of calcium and oleuropein in cells grown in vitro. The disclosure has provided no evidence of a correlation between the degree of muscle fatigue experienced by an exercised subject and the amount of mitochondrial calcium uptake in the tested cell population. There also is no evidence of a correlation between an increase in mitochondrial calcium uptake in cells and a reduction in muscle fatigue experienced by an exercised subject, to any degree. Even if one were to assume the increase in mitochondrial calcium uptake in the tested cells was directly related to decreasing muscle fatigue, there is no nexus between the concentration of calcium and oleuropein employed in the experiment and the orally administered dosing that would be necessary to attain an unexcepted and synergistic degree of decreased muscle fatigue in an exercised subject. In regard to the composition that is claimed, there is no indication of which concentrations produce a synergistic outcome other than the embodiment that was tested. Prior art renders obvious a number of concentration combinations of calcium and oleuropein, in the absence of other compounds that affect mitochondrial calcium import, other than that tested in the showing. Thus the showing is not commensurate in scope with the claims and does not overcome the prima facie cases of obviousness set forth in the rejections.
Additionally, MPEP 716.02(b) details that “[e]vidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. The applicant has not made either comparison because the difference between the prior art method and the claims is not represented by the in vitro test performed by the applicant and the applicant has not tested the prior art.
In order for secondary considerations based upon unexpected results to be persuasive, “[t]he evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance’” (see MPEP 716.02(b)). This requirement of secondary considerations based upon unexpected results also is not met because the applicant has not established the expected outcome for the tested compounds.
Given that olive oil that contains calcium and oleuropein was already orally administered by Musumeci et al., the treatment was seen to improve muscle fatigue in exercised subjects, and was obvious to administer at the claimed timing, the prior art still renders the claimed method obvious. Similarly, the teachings of Hall provide a claimed unit dosage form consisting essentially of numerous pairings of calcium and oleuropein amounts that render the claimed products obvious.
Regarding the double patenting rejections:
The applicant’s acknowledgement of the rejections is noted. However, they will not be held in abeyance. As detailed in MPEP 714.02 “[t]he reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated. Double patenting rejections are not “objections or requirements as to form not necessary to further consideration of the claims” and are not eligible to be held in abeyance.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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