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 .
Formal Matters
Applicant’s arguments in the reply filed on 28 July 2026 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1-20 are pending. Claims 16 and 19 are under consideration in the instant office action. Claims 1-15, 17-18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claims. Applicant’s arguments did not overcome the rejections set forth in the previous office action under 35 USC 103 for reasons set forth in the previous office action and herein below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 January 2026 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. A signed copy is attached.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 16 and 19 remain rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (US Patent No. 8,957,100, IDS reference of February 15, 2024, previously cited) in view of Mehansho et al. (US 2002/0136802, previously cited).
Note: Claims are examined with respect to the elected species of proline nitrate as source of nitrate, elemental magnesium as source of elemental metal, and improving athletic performance as specific intended use
Applicant Claims
Applicant claims a method of increasing the effectiveness of nitrate anion (NO3-) in improving athletic performance in a subject comprising co-administering to the subject an effective amount of a proline nitrate and effective amount of elemental magnesium.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Kramer et al. teach a composition and a supplement formulation includes at least one constituent selected from the group consisting of a nitrate, a nitrite, and both, and Arginine. A method for increasing vasodilative characteristics in a human or animal includes administering to the human or animal a composition or supplement formulation including at least one constituent selected from the group consisting of a nitrate, a nitrite, and both, and Arginine (see abstract). As used herein, “Amino Acid” is a term used in its broadest sense and may refer to an Amino Acid in its many different chemical forms including a single administration Amino Acid, its physiologically active salts or esters, its combinations with its various salts, its tautomeric, polymeric and/or isomeric forms, its analog forms, its derivative forms, its products of biosynthesis, and/or its decarboxylation products. Amino Acids comprise, by way of non-limiting example: Agmatine, Beta Alanine, Arginine, Asparagine, Aspartic Acid, Cysteine, Glutamine, Glutamic Acid, Glycine, Histidine, L-Histidine, Leucine, Isoleucine, Lysine, Methionine, PhenylBeta Alanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Citrulline, Creatine, Glutamine, Norvaline, Ornithine, and Phenylalanine (column 2, lines 5-22). Implementations of an Amino Acid Compound or Composition are particularly useful in increasing bioabsorption and vasodilation in humans and animals. However, implementations are not limited to uses relating to bioabsorption or vasodilation modification, and the like. Rather, any description relating to the foregoing is for the exemplary purposes of this disclosure. It will be understood that implementations of an Amino Acid Compound or Composition may encompass a variety of uses and are not limited in their uses. For example, possible uses may be, by non-limiting example, prevention of Nitrate tolerance, enhanced water solubility, increased distribution to muscles, increased athletic performance, and/or countering Nitric Oxide inhibiting effects of certain Amino Acids (see column 16, lines 44-57). The separating process may be accomplished when the Amino Acid Compound or Composition is in a solid, liquid, or semisolid state(see column 14, lines 47-49). Sports drink compositions are demonstrated in composition 3 and 9 utilizing amino acid nitrates.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Kramer et al. do not teach the inclusion of elemental magnesium. These deficiencies are cured by the teachings of Mehansho et al.
Mehansho et al. teach a beverage compositions comprising:
a) a first component which is arabinogalactan; and
b) a second component comprising one or more minerals selected from the group consisting of zinc, iron, magnesium, calcium, selenium, iodine, and fluorine.
The present compositions are useful to provide beverage compositions which deliver adequate levels of water soluble dietary fiber and important minerals without affecting the product appearance, product taste, and mineral bioavailability. At the same time, the compositions herein deliver the benefits of fiber, one or more of the defined minerals, and/or provide other health benefits, including fighting infection, promoting healthy bacteria, and providing a desired dietary fiber benefit. These and other benefits of the present invention are described herein (see abstract).
As used herein, “magnesium” is inclusive of any compound containing magnesium, including a salt, complex, or other form of magnesium, including elemental magnesium. Acceptable forms of magnesium are well-known in the art (paragraph 0045). Typically, wherein magnesium is utilized herein, at least about 1 milligram of magnesium is included per single dose (i.e., serving size) of the composition. More preferably, when used, at least about 50 milligrams of magnesium is included per single dose of the composition. Most preferably, when used, at least about 100 milligrams of magnesium is included per single dose of the composition. About 400 milligrams of magnesium, per single dose of the composition, is recommended for adult humans. Alternatively, the present compositions comprise from 0% to about 1% magnesium, more preferably from about 0.001% to about 0.8% magnesium, even more preferably from about 0.002% to about 0.6% magnesium, and most preferably from about 0.002% to about 0.5% magnesium, by weight of the composition. As used herein, recitations of mass or weight percent of “magnesium” in any given composition refers to the mass or weight percent of the magnesium-containing component (for example, the amino acid chelated magnesium component), rather than the mass or weight percent of the elemental magnesium which is part of the magnesium-containing component. Of course, wherein elemental magnesium is utilized as the “magnesium”, the mass or weight percent of magnesium in any given composition refers to that of the elemental magnesium (paragraph 0047).
The present compositions are useful to provide beverages which increase the stability and enhance the organoleptic properties of minerals, as well as deliver the benefits of fiber, one or more of the defined minerals, and/or provide other health benefits, including fighting infection, promoting healthy bacteria, and providing a desired dietary fiber benefit. The present compositions deliver dietary fiber and important minerals without the commonly observed problems associated with simultaneous delivery of dietary fiber and minerals including, for example, gelling, viscosity, separation, metallic aftertaste, astringency, and poor bioavailability. These and other benefits of the present invention are described herein (paragraph 0010).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Kramer et al. by incorporating elemental magnesium because Mehansho et al. teach a beverage compositions comprising:
a) a first component which is arabinogalactan; and
b) a second component comprising one or more minerals selected from the group consisting of zinc, iron, magnesium, calcium, selenium, iodine, and fluorine.
The present compositions are useful to provide beverage compositions which deliver adequate levels of water soluble dietary fiber and important minerals without affecting the product appearance, product taste, and mineral bioavailability. At the same time, the compositions herein deliver the benefits of fiber, one or more of the defined minerals, and/or provide other health benefits, including fighting infection, promoting healthy bacteria, and providing a desired dietary fiber benefit. These and other benefits of the present invention are described herein (see abstract).
As used herein, “magnesium” is inclusive of any compound containing magnesium, including a salt, complex, or other form of magnesium, including elemental magnesium. Acceptable forms of magnesium are well-known in the art (paragraph 0045). Typically, wherein magnesium is utilized herein, at least about 1 milligram of magnesium is included per single dose (i.e., serving size) of the composition. More preferably, when used, at least about 50 milligrams of magnesium is included per single dose of the composition. Most preferably, when used, at least about 100 milligrams of magnesium is included per single dose of the composition. About 400 milligrams of magnesium, per single dose of the composition, is recommended for adult humans. Alternatively, the present compositions comprise from 0% to about 1% magnesium, more preferably from about 0.001% to about 0.8% magnesium, even more preferably from about 0.002% to about 0.6% magnesium, and most preferably from about 0.002% to about 0.5% magnesium, by weight of the composition. As used herein, recitations of mass or weight percent of “magnesium” in any given composition refers to the mass or weight percent of the magnesium-containing component (for example, the amino acid chelated magnesium component), rather than the mass or weight percent of the elemental magnesium which is part of the magnesium-containing component. Of course, wherein elemental magnesium is utilized as the “magnesium”, the mass or weight percent of magnesium in any given composition refers to that of the elemental magnesium (paragraph 0047).
One of ordinary skill in the art would have been motivated to include elemental magnesium in the drinks because Mehansho et al. teach that the compositions that contain magnesium are useful to provide beverages which increase the stability and enhance the organoleptic properties of minerals, as well as deliver the benefits of fiber, one or more of the defined minerals, and/or provide other health benefits, including fighting infection, promoting healthy bacteria, and providing a desired dietary fiber benefit. The present compositions deliver dietary fiber and important minerals without the commonly observed problems associated with simultaneous delivery of dietary fiber and minerals including, for example, gelling, viscosity, separation, metallic aftertaste, astringency, and poor bioavailability. These and other benefits of the present invention are described herein (paragraph 0010). Furthermore, in the case where the claimed ranges for amounts of ingredients “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). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, an ordinary skilled artisan would have had a reasonable expectation of success upon combination of the Kramer et al. and Mehansho et al. because both references teach beverage compositions that can enhance health and boost energy.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed on 28 July 2026 have been fully considered but they are not persuasive.
Applicant argues the Examiner’s reason to add elemental magnesium—that both references teach beverages that “enhance health and boost energy”—is a conclusory statement prohibited by KSR and In re Kahn. Neither reference addresses Applicant’s actual problem (increasing the speed/magnitude of nitrate’s ergogenic effect without raising nitrate dose). Kramer’s “comprising” language does not motivate adding a reactive elemental metal. Mehansho is about fiber-stabilized ionic minerals, not nitrate potentiation. A POSITA would have no reason to pick elemental magnesium rather than a conventional ionic salt.
The above assertions are not persuasive because the motivation is not that both references are vaguely “health-related.” Kramer already teaches amino-acid nitrates (including proline) in sports drinks for vasodilation and increased athletic performance (abstract; col. 16, ll. 44–57; compositions 3 and 9). Mehansho teaches that magnesium—expressly including elemental magnesium (paragraph 0045)—is a mineral that can be incorporated into beverage compositions at doses overlapping the claimed effective amounts (at least about 1 mg, preferably 50–100 mg, up to about 400 mg per serving; paragraph 0047) to deliver mineral benefits without destroying appearance, taste, or bioavailability (abstract; paragraph 0010). One of ordinary skilled in the art formulating Kramer’s nitrate sports drink would have been motivated to include a recognized mineral such as magnesium for its known nutritional/physiological role in muscle function and energy metabolism. The law does not require the prior art to recast Applicant’s later-discovered “nitrate-potentiation” problem. In re Kahn, 441 F.3d at 987; Cross Med. Prods., 424 F.3d at 1323. Motivation may be for a different purpose than Applicant’s. That Mehansho also lists salts and chelates does not negate the explicit inclusion of elemental magnesium. Disclosure of alternatives is not a teaching away. In re Fulton, 391 F.3d at 1201. Kramer’s open “comprising” language is not used as the sole motivation; it confirms that additional actives are not excluded once Mehansho supplies a reason to add magnesium.
Applicant argues paragraph 0045 is only a definitional clause, not a working teaching. Every Mehansho example uses ionic salts. Elemental Mg reacts with water (Mg + 2H₂O → Mg(OH)₂ + H₂), causing precipitate, gas, pH rise, and loss of bioavailability—the exact problems Mehansho set out to solve. Under In re Gordon, a modification that renders the prior-art invention unsatisfactory for its intended purpose is not obvious.
The above assertions are not persuasive because Mehansho must be read as a whole. paragraph 0045 is not empty claim-drafting language; it states that “magnesium” includes elemental magnesium and that acceptable forms “are well-known in the art.” Paragraph 0047 then gives dose guidance that applies when elemental magnesium “is utilized as the ‘magnesium.’” That is an affirmative teaching, not a discarded alternative. Absence of a working example using elemental Mg does not erase the teaching. Obviousness does not require the secondary reference to exemplify the exact species later claimed. Gordon does not apply. Mehansho’s intended purpose is delivery of fiber plus minerals in a beverage. Adding elemental magnesium as one listed magnesium form does not prevent that purpose. Applicant has not shown that every Mehansho embodiment would become inoperable. Mehansho also contemplates dry or low-water compositions and optional acidulants, flavorings, and other components (paragraphs 0058, 0122). One of ordinary skill in the art could select dosage form, particle size, coating, or delayed addition—routine choices—without destroying the reference.The cited water-reactivity chemistry describes unbuffered bulk metal in water. It does not establish that no pharmaceutically acceptable presentation of elemental magnesium can exist in a drinkable or reconstitutable product. Applicant’s own specification later shows the combination can be mixed in water; that fact is not used as prior-art motivation, but it undercuts the assertion that the chemistry makes the combination impossible as a matter of law.
Applicant argues one of ordinary skill in the art would have expected precipitation, H₂ evolution, and poor bioavailability. No prior-art example shows a stable aqueous supplement containing elemental Mg. Pointing to Applicant’s Example 6 (elemental Mg + nitrate + citric acid in water) uses the inventor’s own surprising result as prior-art expectation, contrary to W.L. Gore and In re Lee. Industry practice and the NIH ODS fact sheet list only ionic salts.
The above assertions are not found persuasive because reasonable expectation of success is assessed against the claimed method: co-administering an effective amount of a nitrate source with an effective amount of elemental metal to increase nitrate effectiveness/athletic performance. The claims are not limited to a ready-to-drink, indefinitely shelf-stable aqueous beverage identical to Mehansho’s preferred embodiments. Co-administration can be sequential, as a powder-in-water mixture immediately before ingestion, or in other oral forms. Mehansho already contemplates magnesium (including elemental) in compositions that may contain water. Kramer already contemplates nitrate sports drinks. Combining a known mineral form with a known nitrate drink is the kind of predictable combination KSR addresses. Absolute certainty is not required. In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). Example 6 was cited only to answer Applicant’s assertion that elemental Mg + water necessarily produces an explosive/hazardous product. It is not the motivation to combine. The motivation remains Kramer’s performance drinks plus Mehansho’s magnesium teaching. NIH fact sheets and commercial salt lists show common practice; they do not teach away from a form Mehansho expressly includes. Preference for salts is not a teaching away.
Applicant argues neither reference compares nitrate + elemental metal versus nitrate alone on athletic performance. Experiment 12 (100 mg elemental Mg + 1 g proline nitrate + 1 g citric acid; n=12) shows greater aerobic capacity, time to exhaustion, and strength within 5 minutes than inorganic nitrate alone. Under In re Soni, a showing of substantially improved results plus a statement that they were unexpected is sufficient. Because examination is limited to the elected species, Experiment 12 is commensurate; Clemens/Peterson/Grasselli do not apply.
The above assertions are not found persuasive because claim 16 is a method of increasing nitrate effectiveness by co-administering nitrate + elemental metal. Once that combination is obvious, one of ordinary skill in the art would reasonably expect the known effects of each component (nitrate → NO/performance; magnesium → muscle/energy) to be at least additive. Claim 19’s “greater than nitrate alone” language recites a result that flows from adding a second active; it does not confer patentability if the combination itself is obvious. In re Huai-Hung Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011) (functional result of an obvious combination does not make the combination nonobvious). Fuerthermore, Experiment 12 is not commensurate with the full scope of claims 16 and 19 even as examined. Those claims are not limited to 100 mg elemental Mg + 1 g proline nitrate + 1 g citric acid, a 5-minute window, or the three endpoints tested. Claim 16 also recites reducing blood pressure, treating hypertension, and increasing aerobic capacity/stamina/strength/endurance/time to exhaustion as a group. A single-dose, single-acid, n=12 study does not cover that scope. In re Clemens; In re Peterson; MPEP 716.02(d). In re Soni does not eliminate the need for a comparison that is commensurate and for evidence that the difference is unexpected rather than additive. Applicant has not shown that the same improvement occurs across the claimed effective-amount ranges or without the citric acid used in Experiment 12 (acid is not required by claims 16 or 19). Characterization of results as “surprising” in the specification is attorney/inventor assertion, not objective evidence that one of ordinary skill in the art would have found the result unexpected in view of Kramer’s already-taught performance benefit of amino-acid nitrates.
Applicant argues Dr. Bannister applied established chemistry (poor solubility of uncharged metals; exclusive use of salts in supplements; near-zero solubility of elemental Mg). That is not the empty opinion condemned in In re Beattie. The Office cannot demand that Applicant prove Mehansho’s elemental-Mg composition “does not work.” The burden stays with the Office.
The above assertions are not found persuasive because the declaration was considered. It recites general inorganic chemistry and industry custom. It does not include experimental data showing that Mehansho’s compositions, or a Kramer drink modified with elemental magnesium as Mehansho contemplates, fail. Opinion that elemental Mg is “not a bioavailable form” and “would not be considered” by one of ordinary skill in the art cannot override Mehansho’s explicit statement that magnesium includes elemental magnesium and that acceptable forms are well-known (paragraphs 0045, 0047). In re Beattie and Ex parte George remain applicable: conclusory expert statements about what the art “would not consider,” unsupported by testing of the actual proposed combination, have limited weight against an express prior-art teaching. MPEP 716.01(c). The Office is not required to run experiments to disprove a declaration that does not itself test the cited combination. The declaration also does not address the claimed method of co-administration. Even if one of ordinary skill in the art would avoid long-term storage of metal powder in a high-water RTD bottle, that does not establish that co-administering elemental magnesium with a nitrate source (the claim language) would have been unexpected or unsuccessful.
The examiner indicates that Kramer teaches the nitrate/athletic-performance half of the method. Mehansho teaches inclusion of magnesium, including elemental magnesium, in beverage compositions at overlapping amounts. The combination is a predictable use of a known mineral in a known nitrate performance drink. Claim 19’s comparative functional language and Experiment 12 do not rebut obviousness of the combination as claimed. Therefore, the rejection of claims 16 and 19 under 35 U.S.C. § 103 is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
