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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 January 2026 has been entered.
Formal Matters
Applicant’s arguments along with the DECLARATION OF THOMAS D. BANNISTER under 37 C.F.R. § 1.132 in the reply filed on 07 January 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. Claim 1-15, 17-18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking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 statements (IDSs) submitted on 06 November 2025 are 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Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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) in view of Mehansho et al. (US 2002/0136802).
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 June 27, 2025 have been fully considered but they are not persuasive.
Applicant argues Kramer does not disclose elemental metal as an active ingredient, nor does it disclose co-administration of a nitrate with any elemental metal to increase nitrate effectiveness.
The above assertions are not found persuasive because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is based on the combination teachings of the references not Kramer only. The inclusion of elemental magnesium is addressed by the combination teachings of Mehansho.
Applicant then argues the rationale used to combine the reference is too general and does not satisfy the requirement of a "reason with some rational underpinning" (KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398, 418 (2007)) to select the specific combination of (1) a source of nitrate, (2) elemental metal-not a metal salt, chelate, or other form-and (3) co-administration in an amount that increases the effectiveness of nitrate and causes a greater increase in athletic performance for example than nitrate alone. The cited art contains no teaching or suggestion that elemental metal in particular rather than conventional metal salts, chelates, or other forms should be combined with an a nitrate to increase nitrate effectiveness or to obtain superior athletic performance outcomes for example versus nitrate alone. The references at most show that nitrates may improve vasodilation and that magnesium salts may have generalized health benefits. However, the law is clear that obviousness cannot be established by picking and choosing elements from prior art references using the Applicant's disclosure as a blueprint. See, e.g., In re Lee, 277 F.3d 1338, 1344-45 (Fed. Cir. 2002) (rejecting reliance on a conclusory "common knowledge" motivation to combine on a scanty record). Kramer and Mehansho do not provide a motivation to combine to arrive at the claimed method. Kramer’s comprising language does not supply a teaching or motivation to add a reactive elemental metal.
The above assertions are not found persuasive because first the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below). 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.
Applicant continues to argue Mehansho exemplifies only salts and non-metallic forms not elemental magnesium. Elemental magnesium is chemically incompatible with Mehansho's aqueous beverage matrix, defeating any reasonable expectation of success for the Examiner's proposed modification. Mehansho is a beverage-formulation reference focused on delivering
minerals in water-based beverages "without compromising taste, appearance, stability, and bioavailability" and expressly identifies mineral insolubility/instability (settling) and flavors as key formulation problems to be solved. Furthermore, Dr. Bannister's declaration (Declaration of Thomas D. Bannister
Pursuant to 37 C.F.R. § 1.132 dated June 27, 2022; hereinafter Exhibit A), supports the core
technical point that a person of ordinary skill in the art would not view neutral-charged
metallic magnesium as an "acceptable" magnesium source for aqueous beverage
formulations, both because (i) neutral-charged metallic metals are not meaningfully water-
soluble (so they do not behave like beverage minerals) and (ii) elemental magnesium is
hazardous and water-reactive in a manner that undermines beverage stability and safety.
First, Dr. Bannister explains the foundational industry/chemistry premise: "Metals in
their uncharged states are known to a POSA to be generally very poorly water soluble,
relative to metals in most common ionic states. Therefore, their charged state forms, such as
salt forms or oxides, are used for providing metal supplementation in dietary supplement
products." Para 7, Exhibit A. Consistent with that general principle, Bannister states
specifically that "[t]he elemental form of magnesium (in its uncharged state) has near zero
water solubility at room temperature," and therefore "a POSA would not consider the
elemental form of magnesium (in its uncharged state) to be a bioavailable form of
magnesium." Para 8, Exhibit A. Bannister points out that where a reference teaches
administration "after dissolving in water," one of ordinary skill in the art could not,
reasonably interpret that reference as containing any teaching or suggestion for using the
elemental form of magnesium (in its neutral-charged state) because the elemental form has
water solubility of near zero.
The above assertions are not found persuasive because as described above 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). A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983). Regarding the declaration Dr. Bannister's assertions are considered to be expert opinion not objective evidence through an experimental data. The fact that Mehansho et al. teach the inclusion of elemental magnesium in its explicit teachings is not a dispute as the reference speaks itself. It is noted that (expert opinion on what the prior art taught, supported by documentary evidence and formulated prior to the making of the claimed invention, received considerable deference); In re Beattie, 974 F.2d 1309, 24 USPQ2d 1040 (Fed. Cir. 1992) (declarations of seven persons skilled in the art offering opinion evidence praising the merits of the claimed invention were found to have little value because of a lack of factual support); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991) (conclusory statements that results were "unexpected," unsupported by objective factual evidence, were considered but were not found to be of substantial evidentiary value). The declaration does not provide objective data proving Mehansho et al.’s composition including elemental magnesium does not work. Absent a showing of objective data Dr Bannister's expert opinion will not outweigh the explicit teaching by Mehansho et al.
Applicant argues The Office Action's reliance on Applicant's own specification as "another evidence" of what a person of ordinary skill would have expected from the prior art is improper hindsight reasoning not prior-art teaching. Example 6 is not prior art; it is part of Applicant's disclosure describing Applicant's experimental work. The fact that the inventors successfully formulated an elemental metal-nitrate-acid composition in water without causing explosion or acute harm is part of the invention not prior art knowledge. The specification expressly characterizes these findings as "surprising," noting that the combination "resulted in greater and more rapid reduction in blood pressure than the administration of nitrate alone or the typical form of magnesium supplementation alone," despite the known hazards and industry avoidance of elemental magnesium. Appl. [0020].
The above assertions are not found persuasive because first the examiner maintains that contrary to Applicant’s assertions there is no teaching away statement or assertions in Kramer that discourages one of ordinary skill in the art not to include elemental magnesium in the composition of Kramer. Second, Kramer’s claims clearly utilize the transitional phrase “comprising” which does not exclude the inclusion of other actives and ingredients and additional steps. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps."); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to "a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades" encompasses razors with more than three blades because the transitional phrase "comprising" in the preamble and the phrase "group of" are presumptively open-ended. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." Id. In contrast, the court noted the phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. Id. The court also emphasized that reference to "first," "second," and "third" blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group. Thirdly, contrary to Applicant’s assertions there is no explosive occurrence or flammable reactions that happened in Mehansho who teaches the inclusion or incorporation of elemental magnesium in its composition which comprises water in its composition. Mehansho teaches for example, one or more bracers, flavanols, non-caloric sweeteners, vitamins, emulsions, flavoring agents, coloring agents, preservatives, acidulants, water, carbonation components, and/or the like may be included in the compositions herein. Such optional components may be dispersed, solubilized, or otherwise mixed into the present compositions (paragraph 0058). The compositions may comprise from 0% to about 99.999% water, by weight of the composition. Beverage compositions which are not “dry beverage compositions” typically comprise at least about 4% water, preferably at least about 20% water, more preferably at least about 40% water, still more preferably at least about 50% water, even more preferably at least about 75% water, and most preferably at least about 80% water. Still further, ready-to-drink beverage compositions will typically comprise at least about 50% water. The water included at these levels includes all added water and any water present in combination components, for example, fruit juice (paragraph 0122). Mehansho teaches that 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 (see paragraph 0045). Mehansho also clearly teach that 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). There is no evidence to indicate that the inclusion of elemental magnesium in a composition that contains water and other different types of pharmaceutically acceptable ingredients resulted in a flammable and hazardous product as demonstrated by Mehansho’s composition which clearly contains both water and elemental magnesium. Lastly, the examiner also reminds Applicant that another evidence where inflammable and hazardous compositions were not formed when combining elemental magnesium with compositions that contain water is Applicant’s own disclosure which teaches for instance in example 6 to examine whether having any chemical reactions between the inorganic nitrate and the elemental magnesium take place in the stomach is critical for observed effects on blood pressure, the elemental magnesium is mixed with the inorganic nitrate in water prior to administration to a subject. Specifically, 100 mg of elemental magnesium, 300 mg of magnesium nitrate hexahydrate, and 1 g of citric acid were added in water, stirred well for 5 minutes prior to administering the mixture to a male subject. His blood pressure measurements are recorded in the table below. It is very clear Applicant’s composition did not result in inflammable and hazardous composition.
To be clear obviousness does not require the reference to teach the claimed elemental magnesium in specific example. A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983). Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.").
Applicant argues for athletic performance, Experiment 12 reports that twelve subjects receiving a composition comprising 100 mg elemental magnesium, 1 g proline nitrate, and 1 g citric acid experienced statistically significant increases in aerobic capacity, time to exhaustion, and muscle strength within just 5 minutes of administration, and that "the amount of increase [...] was much greater than the amount of increase from administration of just inorganic nitrates." Appl. [0056]. This is precisely the functional requirement of claim 19: greater increase in athletic performance than with the corresponding amount of nitrate alone.
The above assertions are not found persuasive because Whether 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. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
Conclusion
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619