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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18, 2026 has been entered.
Election/Restrictions
To summarize the current election, the applicant elected Group II and Species B, per the revised restriction organization detailed in the Office action mailed November 27, 2024, drawn to a method of achieving improvement in at least one of muscle functionality, muscle performance, or muscle strength in the tibialis comprising orally administering effective amount of calcium and at least one of oleuropein, oleuropein aglycone, hydroxytyrosol, homovanillyl alcohol, isohomovanillyl alcohol to an individual.
Claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34 and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims add caffeine to the composition orally administered to a subject address at least one of muscle functionality, muscle performance, or muscle strength. Caffeine is not disclosed as a contemplated part of the composition administered to a subject. It only arises in the disclosure in in vitro cell tested to stimulate cells so as to assess mitochondrial activity (see examples 1 and 2). Thus it would not have been clear to the artisan of ordinary skill that the applicant contemplated (had possession of) the invention as currently claimed at the time of filing of the instant application.
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 1-4, 18-19, and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. (previously cited) in view of Edwards et al. (US PGPub No. 2006/0216361) and Horcajada et al. (CA 3224027 - previously cited) as evidenced by Lee (US PGPub No. 2013/0108721).
Coxam et al. teach orally administering oleuropein compositions composed of oleuropein or a metabolite/derivative formulated as an oral nutritional composition intended to support bone health (see abstract and paragraphs 49, 75, 107, and 114; instant claims 11-13). The patient population of interest includes aging humans and animals, and in particular those with or prone to developing osteoporosis (see paragraphs 13-15 and 105). The oleuropein occurs in olive fruit and may be purified from an extract (see paragraphs 78 and 87). They go on to teach the inclusion of a calcium source in the nutritional composition as an additional nutritional compound in various salt forms that are envisioned as calcium carbonate, calcium chloride, and calcium citrate (see paragraph 133-134; instant claim 20). Coxam et al. further teach the inclusion of vitamins and minerals in the compositions (see paragraphs 135 and 136). Envisioned vitamins include folic acid (acidulant), vitamin C (acidulent), vitamin B1 (thiamin) vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (panthothenic acid), vitamin B12, and vitamin D (see paragraph 135). The envisioned minerals include magnesium (see paragraph 136). Additionally, carbohydrate compounds such as various fiber compounds, monosaccharides, and polysaccharides are envisioned for inclusion as well (see paragraphs 137-138). Coxam et al. teach the composition in various forms such as tablets and capsules as well as liquid forms such as beverages aqueous/oily suspensions and emulsions (see paragraphs 114-116 and 165-166). Coxam et al. teach the inclusion of formulation excipients along with the oleuropein (see paragraph 155). Various amounts for daily administration of the oleuropein or a metabolite/derivative is detailed as 0.01 to 200 mg and that for calcium is detailed as 100 to 1000 mg (see paragraphs 130 and 134; instant claims 18-19 and 27-28). They teach administration to pets as well as young developing humans, and aging humans (see paragraphs 94, 147, and 151; instant claims 2 and 31). An example explicitly pairing calcium and oleuropein is not provided nor is the composition discussed in regard to its impact on muscles.
Edwards et al. teach a composition for supporting bone health and protection against bone loss (see abstract). The composition includes a calcium source, folic acid, a vitamin D, vitamin B12, and magnesium (see paragraph 11 and example 1). In addition, they also envision the inclusion of other vitamins and excipients (see paragraphs 11 and 77). The additional vitamins include vitamin B1, vitamin B2, vitamin B3 (niacinamide), vitamin B5 (panthothenic acid), and vitamin C (see paragraph 14). Edwards et al. teach selecting amongst well known calcium compounds for supplementation for the calcium source and they include calcium carbonate, calcium lactate, and calcium gluconate (see paragraph 32).
Horcajada et al. teach increasing (improving) muscle functionality in an individual by administering a composition with a therapeutically effective amount of oleuropein (see paragraph 1, claim 10, and paragraph 57). They detail that muscle functionality performance and structure are decreased due to aging (e.g., otherwise healthy) (see paragraphs 5-6 and 8, and 107; instant claim 31). Patients of interest include human adults which are explicitly envisioned to include the elderly, where administration yields improved muscle functionality (e.g. vitality) (see paragraphs 4, 49-50, and 80). Muscles impacted by the method are preferably skeletal muscle and include the tibialis amongst particular envisioned varieties (see paragraph 59; instant claim 3). Horcajada et al. further envision the presence of vitamin D, a protein source such as the preferred whey protein as well as free from amino acids that include leucine (see paragraphs 68 and 78-79). Daily administration of the composition is taught as is an administration duration of 30 days and longer (see paragraph 82; instant claim 4). The oleuropein is envisioned as a variety of polyphenol in the composition and this category of ingredient is present at 0.01 mg to 1000 mg per serving (see paragraphs 64-65; instant claims 18-19). They orally administer the composition to advanced age mammals as part of the diet over the course of three months and assess the impact on walking (gait) speed (see paragraph 107; instant claim 31). Walking is a variety of exercise and administration as part of the diet equates to administration before and after exercise (see instant claim 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orally administer an embodiment of Coxam et al., where a calcium compound and other envisioned vitamins and minerals are included with the oleuropein because they teach to do so. The patient population of Coxam et al. overlaps with that of Horcajada et al., where both envision their composition being administered to older/elderly adults to preserve and improve the function of tissues important for movement. The addition of the combination of calcium source, folic acid, a vitamin D, vitamin B12, and magnesium as taught by Edwards et al. would have been obvious because these added vitamins and mineral are contemplated by Coxam et al and envisioned in combination by Edwards for the same general purpose envisioned by Coxam et al. Amongst the calcium compounds the selection of calcium lactate or calcium gluconate, specifically would follow because they are well known compounds for calcium supplementation that Edwards et al teach. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulent), a vitamin D, vitamin B12, and magnesium (see Lee paragraph 61). Providing a daily dose of oleuropein at 0.01 to 200 mg daily and calcium at 100 to 1000 mg would follow as would administering taught dosing ranges and dosing forms detailed by Coxam et al. These dosing ranges overlap with those instantly recited, thereby rendering the claimed ranges obvious (see instant claim 18-19 and 27). “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). Horcajada et al. teach the daily oral administration of a similar concentration of oleuropein and detail that it also improves functionality in muscle in general and in the tibialis, in particular. The application of their administration duration would have been obvious since it is the same main active compound that is also administered daily via the teaching Coxam et al. Daily administration over this duration meets the limitation of before and after exercise timing amongst the walking subset of the subject population. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here the instantly claimed composition is administered at the instantly claimed dose, via the instantly claimed route, to the instantly claimed patient population, therefore the instantly claimed outcomes should be the result, absent evidence to the contrary (see instant claims 1 and 30-31). Thus claims 1-4, 18-19, and 27-31 are obvious over Coxam et al. in view of Edwards et al. and Horcajada et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Edwards et al. and Horcajada et al. as evidenced by Lee as applied to claims 1-4, 18-19, and 27-31 above, and further in view of Westerlund et al. (US PGPub No. 2014/0161784).
Coxam et al. in view of Edwards et al. and Horcajada et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, and 27-31. While the instantly claimed components of claim 33 are envisioned, the combination of magnesium and vitamins instantly claimed is not exemplified.
Westerlund et al. teach a composition that is a combination of vitamins and minerals to support recovery after exercise as well as after surgery (see abstract). The mixture of minerals and vitamins includes folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, and magnesium (see table 2; instant claim 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the mineral and vitamin combination detailed by Westerlund et al. in the composition administered in the modified teachings of Coxam et al. This modification would have been obvious because the mixture is known for a similar improvement outcome and includes a number of components already contemplated in the composition of Coxam et al. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, and magnesium. Therefore claims 1-4, 18-19, 27-31, and 33 are obvious over Coxam et al. in view of Edwards et al., Horcajada et al., and Westerlund et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Edwards et al., Horcajada et al., and Westerlund et al. as evidenced by Lee as applied to claims 1-4, 18-19, 27-31, and 33 above, and further in view of Morita (JP 2005006626 – English translation relied upon for citations).
Coxam et al. in view of Edwards et al., Horcajada et al., and Westerlund et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-31, and 33. Coxam et al. teach that various soluble fiber (carbohydrate) compounds are envisioned for inclusion as well (see paragraphs 137-138). Horcajada et al. teach the inclusion of oleuropein as a polyphenol compound and note coffee as an additional source of this class of compounds (see abstract and paragraph 63). Caffeine is not explicitly noted as a component of the coffee.
Morita teaches of benefits of coffee in combination with a vitamin blend for bone health maintenance (see abstract). The vitamins include vitamins B1 and B2 which they note as acting synergistically with caffeine that is also present (see paragraphs 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the soluble fiber already contemplated by Coxam et al. as well as polyphenols of coffee along with its caffeine in the composition administered in the modified teachings of Coxam et al. These modifications are obvious in light of the teachings of Horcajada et al. concerning polyphenols and those of Morita concerning the coffee in combination with B vitamins. These modifications 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 comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, carbohydrate, and caffeine. Therefore claims 1-4, 18-19, 27-31, and 33-34 are obvious over Coxam et al. in view of Edwards et al., Horcajada et al., Westerlund et al., and Morita as evidenced by Lee.
Claims 1-4, 18-19, 27-31, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Edwards et al. and Horcajada et al. as evidenced by Lee as applied to claims 1-4, 18-19, and 27-31 above, and further in view of Hartl et al. (US PGPub No. 2013/0177542).
Coxam et al. in view of Edwards et al. and Horcajada et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, and 27-31. Horcajada et al. teach the inclusion of whey protein. While the instantly claimed components of claims 33 and 35 are envisioned, the combination of magnesium and vitamins instantly claimed is not exemplified.
Hartl et al. teach a composition that is a combination of amino acids, vitamins and minerals to support bone health (see abstract). The mixture of amino acids, minerals, and vitamins include chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine that are administered at a single time (see paragraph 11 and listing 1 breakfast; instant claim 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include whey protein, in light of Horcajada et al., in the composition administered in the modified teachings of Coxam et al. because it would benefit the patient population being treated. In addition the inclusion of the amino acid, mineral, and additional vitamin combination detailed by Hartl et al. also would have been obvious because it is known for a similar bone improvement outcome and includes a number of components already contemplated in the composition of Coxam et al. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine. Therefore claims 1-4, 18-19, 27-31, 33, and 35 are obvious over Coxam et al. in view of Edwards et al., Horcajada et al., and Hartl et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-33, 35-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Edwards et al., Horcajada et al., and Hartl et al. as evidenced by Lee as applied to claims 1-4, 18-19, 27-31, 33, and 35 above, and further in view of Horcajada et al. (US PGPub No. 2016/0045519– henceforth Horcajada B).
Coxam et al. in view of Edwards et al., Horcajada et al., and Hartl et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-31, 33, and 35 which also include most of the limitations of instant claims 32, 36, and 38. Coxam et al. teach the inclusion of formulation excipients along with the oleuropein. They also envision fiber compounds in the composition that include acacia gum (see paragraph 137). Gum arabic is not explicitly taught by the modified teachings.
Horcajada B teaches a composition to support bone health (see abstract). Amongst envisioned components, they teach fiber compounds such as gum arabic and acacia gum (see paragraph 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an excipient and gum arabic as a fiber compound, in light of Horcajada B, in the composition administered in the modified teachings of Coxam et al. because Coxam et al. already include an excipient and contemplate an overlapping scope of fiber compounds with those of Horcajada B. The selection of the fiber compounds of Horcajada B is obvious because Coxam et al. suggest their benefit and as the simple substitution of one known element for another. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, gum arabic, excipient, chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine folic acid (acidulent), a vitamin D, vitamin B12, and magnesium. Therefore claims 1-4, 18-19, 27-33, 35-36, and 38 are obvious over Coxam et al. in view of Edwards et al., Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee.
Claims 1-4, 18-19, and 27-38 are rejected under 35 U.S.C. 103 as being unpatentable over Coxam et al. in view of Edwards et al., Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee as applied to claims 1-4, 18-19, 27-33, 35-36, and 38 above, and further in view of Morita.
Coxam et al. in view of Edwards et al., Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-33, 35-36, and 38. Coxam et al. teach various soluble fiber (carbohydrate) compounds are envisioned for inclusion as well (see paragraphs 137-138). Horcajada et al. teach the inclusion of oleuropein as a polyphenol compound and note coffee as an additional source of this class of compounds (see abstract and paragraph 63). Caffeine is not explicitly noted as a component of the coffee.
Morita teaches of benefits of coffee in combination with a vitamin blend for bone health maintenance (see abstract). The vitamins include vitamins B1 and B2 which they note as acting synergistically with caffeine that is also present (see paragraphs 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the soluble fiber already contemplated by Coxam et al. as well as polyphenols of coffee along with its caffeine in the composition administered in the modified teachings of Coxam et al. These modifications are obvious in light of the teachings of Horcajada et al. concerning polyphenols and those of Morita concerning the coffee in combination with B vitamins. These modifications 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 comprising oleuropein, calcium lactate or calcium gluconate, excipient, arabic gum, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, chondroitin (carbohydrate), and caffeine. Therefore claims 1-4, 18-19, and 27-38 are obvious over Coxam et al. in view of Edwards et al., Horcajada et al., Hartl et al., Horcajada B, and Morita as evidenced by Lee
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 double patenting rejections are discussed in aggregate due to the repetition amongst the claims and for the sake of brevity.
Although the claims at issue are not identical, they are not patentably distinct from each other because
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407 administer a composition to a subject that comprises an ingredient for muscle and/or bone quality comprising an ingredient for muscle quality and/or functionality comprising a protein source and an ingredient for joint quality comprising a polyphenol. The recitation of an ingredient for muscle and/or bone quality comprising an ingredient for muscle quality and/or functionality suggests the intent to improve muscle quality and/or functionality. At least weekly administration is recited as well, this frequency range The polyphenol is recited to be selected from three options where oleuropein is named. The ingredient for muscle and/or bone quality is recited to be selected from a small set of options that include calcium as well as vitamin D and the duration of administration is recited to be at least one week. Whey protein is also present. Oral administration is not explicitly recited.
Claims 1-4 of U.S. Patent No. 10,751,357 recite a method of increasing muscle functionality in an individual by administering a composition that comprises oleuropein and whey protein.
claims 1-2 and 8 of U.S. Patent No. 11,813,273 recite a method of increasing muscle functionality in an individual by administering a composition that comprises oleuropein and whey protein. The administration occurs daily.
Claims 1-9 of U.S. Patent No. 11,364,254 recites a method of increasing muscle functionality in an individual in need thereof, the method comprising administering to the individual a composition comprising 0.01 mg to about 1.0 g of oleuropein, leucine, isoleucine and valine, Vitamin D, and (v) whey protein
Claims 1-4, 18-19, and 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee.
Coxam et al. teach orally administering oleuropein compositions composed of oleuropein or a metabolite/derivative formulated as an oral nutritional composition intended to support bone health (see abstract and paragraphs 49, 75, 107, and 114; instant claims 11-13). The patient population of interest includes aging humans and animals, and in particular those with or prone to developing osteoporosis (see paragraphs 13-15 and 105). The oleuropein occurs in olive fruit and may be purified from an extract (see paragraphs 78 and 87). They go on to teach the inclusion of a calcium source in the nutritional composition as an additional nutritional compound in various salt forms that are envisioned as calcium carbonate, calcium chloride, and calcium citrate (see paragraph 133-134; instant claim 20). Coxam et al. further teach the inclusion of vitamins and minerals in the compositions (see paragraphs 135 and 136). Envisioned vitamins include folic acid (acidulant), vitamin C (acidulent), vitamin B1 (thiamin) vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (panthothenic acid), vitamin B12, and vitamin D (see paragraph 135). The envisioned minerals include magnesium (see paragraph 136). Additionally, carbohydrate compounds such as various fiber compounds, monosaccharides, and polysaccharides are envisioned for inclusion as well (see paragraphs 137-138). Coxam et al. teach the composition in various forms such as tablets and capsules as well as liquid forms such as beverages aqueous/oily suspensions and emulsions (see paragraphs 114-116 and 165-166). Coxam et al. teach the inclusion of formulation excipients along with the oleuropein (see paragraph 155). Various amounts for daily administration of the oleuropein or a metabolite/derivative is detailed as 0.01 to 200 mg and that for calcium is detailed as 100 to 1000 mg (see paragraphs 130 and 134; instant claims 18-19 and 27-28). They teach administration to pets as well as young developing humans, and aging humans (see paragraphs 94, 147, and 151; instant claims 2 and 31). An example explicitly pairing calcium and oleuropein is not provided nor is the composition discussed in regard to its impact on muscles.
Edwards et al. teach a composition for supporting bone health and protection against bone loss (see abstract). The composition includes a calcium source, folic acid, a vitamin D, vitamin B12, and magnesium (see paragraph 11 and example 1). In addition, they also envision the inclusion of other vitamins and excipients (see paragraphs 11 and 77). The additional vitamins include vitamin B1, vitamin B2, vitamin B3 (niacinamide), vitamin B5 (panthothenic acid), and vitamin C (see paragraph 14). Edwards et al. teach selecting amongst well known calcium compounds for supplementation for the calcium source and they include calcium carbonate, calcium lactate, and calcium gluconate (see paragraph 32).
Horcajada et al. teach increasing (improving) muscle functionality in an individual by administering a composition with a therapeutically effective amount of oleuropein (see paragraph 1, claim 10, and paragraph 57). They detail that muscle functionality performance and structure are decreased due to aging (e.g., otherwise healthy) (see paragraphs 5-6 and 8, and 107; instant claim 31). Patients of interest include human adults which are explicitly envisioned to include the elderly, where administration yields improved muscle functionality (e.g. vitality) (see paragraphs 4, 49-50, and 80). Muscles impacted by the method are preferably skeletal muscle and include the tibialis amongst particular envisioned varieties (see paragraph 59; instant claim 3). Horcajada et al. further envision the presence of vitamin D, a protein source such as the preferred whey protein as well as free from amino acids that include leucine (see paragraphs 68 and 78-79). Daily administration of the composition is taught as is an administration duration of 30 days and longer (see paragraph 82; instant claim 4). The oleuropein is envisioned as a variety of polyphenol in the composition and this category of ingredient is present at 0.01 mg to 1000 mg per serving (see paragraphs 64-65; instant claims 18-19). They orally administer the composition to advanced age mammals as part of the diet over the course of three months and assess the impact on walking (gait) speed (see paragraph 107; instant claim 31). Walking is a variety of exercise and administration as part of the diet equates to administration before and after exercise (see instant claim 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orally administer the composition of the patented claims modified in light of Coxam et al., where a calcium compound and other envisioned vitamins and minerals are included with the oleuropein because they teach to do so. The patient populations of patented claims, Coxam et al. and Horcajada et al. overlap, where they envision their composition being administered to older/elderly adults to preserve and improve the function of tissues important for movement or would be beneficial to this population due to the improvement in function they produce. The addition of the combination of calcium source, folic acid, a vitamin D, vitamin B12, and magnesium as taught by Edwards et al. would have been obvious because these added vitamins and mineral are contemplated by Coxam et al. and envisioned in combination by Edwards for the same general purpose envisioned by Coxam et al. Amongst the calcium compounds the selection of calcium lactate or calcium gluconate, specifically would follow because they are well known compounds for calcium supplementation that Edwards et al teach. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulent), a vitamin D, vitamin B12, and magnesium (see Lee paragraph 61). Providing a daily dose of oleuropein at 0.01 to 200 mg daily and calcium at 100 to 1000 mg would follow as would administering taught dosing ranges and dosing forms detailed by Coxam et al. These dosing ranges overlap with those instantly recited, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Horcajada et al. teach the daily oral administration of a similar concentration of oleuropein and detail that it also improves functionality in muscle in general and in the tibialis, in particular. The application of their administration duration would have been obvious since it is the same main active compound that is also administered via the patented claims and the teaching Coxam et al. Daily administration over this duration meets the limitation of before and after exercise timing amongst the walking subset of the subject population. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Here the instantly claimed composition is administered at the instantly claimed dose, via the instantly claimed route, to the instantly claimed patient population, therefore the instantly claimed outcomes should be the result, absent evidence to the contrary (see instant claims 1 and 30-31). Thus claims 1-4, 18-19, and 27-31 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee as applied to claims 1-4, 18-19, and 27-31 above, and further in view of Westerlund et al.
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, and 27-31. While the instantly claimed components of claim 33 are envisioned, the combination of magnesium and vitamins instantly claimed is not exemplified.
Westerlund et al. teach a composition that is a combination of vitamins and minerals to support recovery after exercise as well as after surgery (see abstract). The mixture of minerals and vitamins includes folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, and magnesium (see table 2; instant claim 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the mineral and vitamin combination detailed by Westerlund et al. in the composition administered in the modified method of the patented claims. This modification would have been obvious because the mixture is known for a similar improvement outcome and includes a number of components already contemplated in the composition of Coxam et al. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, and magnesium. Therefore claims 1-4, 18-19, 27-31, and 33 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al., Horcajada et al. and Westerlund et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al., Horcajada et al. and Westerlund et al. as evidenced by Lee as applied to claims 1-4, 18-19, 27-31, and 33 above, and further in view of Morita.
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al., Horcajada et al. and Westerlund et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-31, and 33. Coxam et al. teach that various soluble fiber (carbohydrate) compounds are envisioned for inclusion as well (see paragraphs 137-138). Horcajada et al. teach the inclusion of oleuropein as a polyphenol compound and note coffee as an additional source of this class of compounds (see abstract and paragraph 63). Caffeine is not explicitly noted as a component of the coffee.
Morita teaches of benefits of coffee in combination with a vitamin blend for bone health maintenance (see abstract). The vitamins include vitamins B1 and B2 which they note as acting synergistically with caffeine that is also present (see paragraphs 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the soluble fiber already contemplated by Coxam et al. as well as polyphenols of coffee along with its caffeine in the composition administered in the modified method of the patented claims. These modifications are obvious in light of the teachings of Horcajada et al. concerning polyphenols and those of Morita concerning the coffee in combination with B vitamins. These modifications 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 comprising oleuropein, calcium lactate or calcium gluconate, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, carbohydrate, and caffeine. Therefore claims 1-4, 18-19, 27-31, and 33-34 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al., Horcajada et al. Westerlund et al. and Morita as evidenced by Lee.
Claims 1-4, 18-19, 27-31, 33, and are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee as applied to claims 1-4, 18-19, and 27-31 above, and further in view of Hartl et al.
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, and 27-31. While the instantly claimed components of claims 33 and 35 are envisioned, the combination of magnesium and vitamins instantly claimed is not exemplified.
Hartl et al. teach a composition that is a combination of amino acids, vitamins and minerals to support bone health (see abstract). The mixture of amino acids, minerals, and vitamins include chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine that are administered at a single time (see paragraph 11 and listing 1 breakfast; instant claim 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include whey protein in the composition administered in the modified method of patented claims because they recite to do so. In addition the inclusion of the amino acid, mineral, and additional vitamin combination detailed by Hartl et al. also would have been obvious because it is known for a similar bone improvement outcome and includes a number of components already contemplated in the composition of Coxam et al. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine. Therefore claims 1-4, 18-19, 27-31, 33, and 35 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., and Hartl et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-33, 35-36, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., and Hartl et al. as evidenced by Lee as applied to claims 1-4, 18-19, 27-31, 33, and 35 above, and further in view of Horcajada B.
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., and Hartl et al. as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-31, 33, and 35 which also include most of the limitations of instant claims 32, 36, and 38. Coxam et al. teach the inclusion of formulation excipients along with the oleuropein. They also envision fiber compounds in the composition that include acacia gum (see paragraph 137). Gum arabic is not explicitly taught by the modified teachings.
Horcajada B teaches a composition to support bone health (see abstract). Amongst envisioned components, they teach fiber compounds such as gum arabic and acacia gum (see paragraph 64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an excipient and gum arabic as a fiber compound, in light of Horcajada B, in the composition administered in the modified method of the patented claims because Coxam et al. already include an excipient and contemplate an overlapping scope of fiber compounds with those of Horcajada B. The selection of the fiber compounds of Horcajada B is obvious because Coxam et al. suggest their benefit and as the simple substitution of one known element for another. The result is a composition comprising oleuropein, calcium lactate or calcium gluconate, gum arabic, excipient, chondroitin (carbohydrate), folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, isoleucine, leucine, and valine folic acid (acidulent), a vitamin D, vitamin B12, and magnesium. Therefore claims 1-4, 18-19, 27-33, 35-36, and 38 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee.
Claims 1-4, 18-19, and 27-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee as applied to claims 1-4, 18-19, 27-33, 35-36, and 38 above, and further in view of Morita.
Claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee render obvious the limitations of instant claims 1-4, 18-19, 27-33, 35-36, and 38. Coxam et al. teach various soluble fiber (carbohydrate) compounds are envisioned for inclusion as well (see paragraphs 137-138). Horcajada et al. teach the inclusion of oleuropein as a polyphenol compound and note coffee as an additional source of this class of compounds (see abstract and paragraph 63). Caffeine is not explicitly noted as a component of the coffee.
Morita teaches of benefits of coffee in combination with a vitamin blend for bone health maintenance (see abstract). The vitamins include vitamins B1 and B2 which they note as acting synergistically with caffeine that is also present (see paragraphs 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the soluble fiber already contemplated by Coxam et al. as well as polyphenols of coffee along with its caffeine in the composition administered in the modified method of the patented claims. These modifications are obvious in light of the teachings of Horcajada et al. concerning polyphenols and those of Morita concerning the coffee in combination with B vitamins. These modifications 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 comprising oleuropein, calcium lactate or calcium gluconate, excipient, arabic gum, folic acid (acidulant), vitamin C, vitamin B1 vitamin B2, vitamin B3, vitamin B5, vitamin B12, vitamin D, magnesium, chondroitin (carbohydrate), and caffeine. Therefore claims 1-4, 18-19, and 27-38 are obvious over claims 1, 5-6, 12, and 14-16 of U.S. Patent No. 11,123,407, claims 1-4 of U.S. Patent No. 10,751,357, claims 1-2 and 8 of U.S. Patent No. 11,813,273, and claims 1-9 of U.S. Patent No. 11,364,254, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. Horcajada B, and Morita as evidenced by Lee.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329 recite achieving improvement in at least one of muscle functionality, muscle performance, or muscle strength by administering a composition comprising oleuropein to a subject in need thereof. Oral administration is not explicitly recited.
Claims 1-4, 18-19, and 27-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al. and Horcajada et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al., Horcajada et al. and Westerlund et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al., Horcajada et al. Westerlund et al. and Morita as evidenced by Lee.
Claims 1-4, 18-19, 27-31, 33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., and Hartl et al. as evidenced by Lee.
Claims 1-4, 18-19, 27-33, 35-36, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. and Horcajada B as evidenced by Lee.
Claims 1-4, 18-19, 27-31, and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of Coxam et al., Edwards et al. and Horcajada et al., Hartl et al. Horcajada B, and Morita as evidenced by Lee.
The rationale for obvious associated with each of the statements of provisional rejection parrot the same rationale detailed above for the non-provisional rejections of the same sets of claims modified by the same references. The exception is the further obviousness of the inclusion of whey protein in light of Horcajada et al. Therefore claims 1-4, 18-19, and 27-38 are obvious over claims 1-12 of copending US Application No. 18/866347 and claims 1-17 of copending US Application No.18/ 866329, each separately in view of the associated collection of cited prior art.
Response to Arguments
Applicant's arguments filed May 18, 2026 have been fully considered. In light of the amendment to the claims, the rejections are modified to address the new claim limitations. New ground of rejection are made concerning the new claim limitations and are not persuasive.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
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