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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 05/20/2026 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims and/or persuasive remarks: (1) the 35 U.S.C. 112(b) rejection of claim 3 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-30
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: None
Amended claims: 1 and 3
New claims: None
Claims currently under consideration: 1-30
Currently rejected claims: 1-30
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12, 17-25, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (U.S. 2005/0100637 A1) in view of Wilburn et al. (Wilburn, D., Machek, S., and Ismaeel, A., “Highly Branched Cyclic Dextrin and its Ergogenic Effects in Athletes: A Brief Review,” Journal of Exercise and Nutrition, Volume 4 (Issue 3): 15, 1-8, (2021)).
Regarding claim 1, Murray et al. discloses a hydration composition ([0001], [0015]) comprising a glucose-specific source comprising free glucose and sucrose, where the total carbohydrate content of the composition is in the range of about 6-8% (w/v) ([0062]), where the composition has a working osmolality of about 200-300 mOsm/kg ([0016], [0072]) and an electrolyte ([0013], [0055]), wherein the hydration composition is a liquid ([0013]).
Murray et al. does not disclose the inclusion of polymeric dextrin from the claimed group or the polymeric dextrin as being in an amount sufficient to provide a sustained release of energy while maintaining the working osmolality level that promotes optimal hydration.
However, Wilburn et al. discloses the use of highly-branched cyclic dextrin (HBCD) as a low osmolality carbohydrate supplement (p. 1, ¶1) in sports drinks (p. 2, ¶3), where HBCD meets the claimed criteria for the polymeric dextrin (a carbohydrate comprising a plurality of monosaccharide units that are branched or cyclic and that is a polymeric dextrin comprising cyclic monosaccharide units) (p. 2, Figure 1). Wilburn et al. further discloses using HBCD at an amount sufficient to provide a sustained release of energy (“[p]erformance claims of HBCD include the ability to help boost exercise endurance”, p. 2, ¶3; “HBCD may provide increased performance or endurance compared to other carbohydrates sources, such as maltodextrin and glucose”, p. 6, ¶1) while maintaining osmolality that promotes optimal hydration (“Due to a lower osmolality, HBCD results in a faster [gastric emptying time] compared to glucose, thus resulting in faster elevated blood glucose levels”, p. 4, ¶2; “carbohydrates with a low osmolality may be more effective for providing energy during exercise and expediting glycogen synthesis post-training”, p. 3, ¶3).
It would have been obvious to one having ordinary skill in the art to incorporate HBCD as a carbohydrate into the hydration composition of Murray et al., such that the claimed polymeric dextrin limitations would be met. Since Murray et al. indicates that the composition may comprise a carbohydrate and provides a list of exemplary suitable carbohydrates, including several that are known to impart sweetness, but indicates that the list is “not limited to” the noted carbohydrates ([0062]), a skilled practitioner would be motivated to consult Wilburn et al. for instruction regarding additional suitable components. Since Wilburn et al. discloses the suitability of HBCD as a low osmolality carbohydrate supplement (p. 1, ¶1) in sports drinks (p. 2, ¶3) and further indicates its superiority over maltodextrin and glucose for such purposes (p. 6, ¶1) (where maltodextrin and glucose are taught in Murray et al. as being suitable carbohydrates, [0062]), the incorporation of HBCD into the composition of Murray et al. would be obvious to a skilled practitioner, which renders obvious the claimed polymeric dextrin component and its relevant limitations, including its addition in an amount that achieves an osmolality in the claimed range of about 200-300 mOsm/kg.
As for claim 2, Murray et al. discloses composition further comprises glucose and fructose at a ratio from about 3:1 to about 1:3 (e.g., 1.5% glucose and 1.5% fructose) ([0062]).
As for claim 3, Wilburn et al. discloses the HBCD comprises a plurality of monosaccharide units each having at least 3 carbon atoms branched with an oxygen atom bonded to each carbon atom (p. 2, Figure 1, where glucose units meet the claimed criteria).
As for claim 4, Murray et al. discloses the composition as further comprising a carbohydrate that is not glucose-specific ([0062]).
As for claim 5, Murray et al. discloses the carbohydrate that is not glucose-specific as being fructose ([0062]).
As for claim 6, Murray et al. discloses glucose and fructose as being in a ratio from about 5:1 to about 1:5 ([0062]).
As for claim 7, Murray et al. discloses the glucose-specific source as being in a range from about 1-20% (w/v) of the composition ([0062]).
As for claim 8, Murray et al. discloses the electrolyte as being sodium ([0063]).
As for claim 9, Murray et al. discloses the liquid as being a beverage ([0013]).
As for claim 10, Murray et al. discloses the beverage as being a sports drink ([0013]).
As for claim 11, Murray et al. discloses the composition as further comprising a flavoring agent ([0070]).
As for claim 12, Murray et al. discloses the flavoring agent as being orange ([0071]).
As for claim 17, Murray et al. discloses the composition as comprising a preservative that is citric acid ([0074]).
As for claim 18, Murray et al. discloses the composition as having a glucose-to-fructose ratio of about 1:1 ([0062]), a working osmolality of about 210-268 mOsm/kg ([0072]), and a total carbohydrate content in the range of about 6-8% (w/v) ([0062]).
As for claim 19, Murray et al. discloses a method of providing hydration and fuel to a subject comprising providing the subject with the hydration composition that maintains hydration and provides fuel ([0054], [0100]).
As for claim 20, Murray et al. discloses that providing the hydration composition maintains proper fluid balance ([0054]) and supports muscle function ([0011], where ameliorating the adverse physiological effects of physical exertion is considered to fall within the scope of supporting muscle function).
As for claim 21, Murray et al. discloses the hydration composition as being provided in an amount sufficient to offset the loss of water through sweating ([0100], [0140]).
As for claim 22, Murray et al. discloses the hydration composition as being formulated to enhance fluid retention ([0054]) and sustain metabolic function in the subject ([0013], where supplying energy sources is considered to fall within the scope of sustaining metabolic function).
As for claim 23, Murray et al. discloses the hydration composition provides cellular uptake of fluids ([0008]-[0009], [0066], [0067]) and provides immediate and sustained energy to the subject ([0013]).
As for claim 24, Murray et al. discloses the subject as being engaged in physical exertion ([0011]) and the hydration composition as providing sustained hydration and fuel while the subject is engaged in physical exertion (claim 169, where administration occurs during activity-induced fluid loss).
As for claim 25, Murray et al. discloses the composition supports prolonged endurance and reduces a risk of dehydration-related fatigue (claim 169, where reducing the effects of dehydration would include dehydration-related fatigue, which would likewise support prolonged endurance).
As for claim 27, Murray et al. discloses administering a hydration composition proportional to the sweat lost during vigorous exercise ([0100]), which renders obvious the claimed limitation that the hydration composition is formulated for a personalized use based on an individual athletic performance.
As for claim 28-30, Murray et al. discloses the method of claim 19 and the composition of claim 1. Murray et al. also discloses that the compositions “may be used to attenuate or reverse the effects of dehydration or other adverse effects of exercise, heat or other activity which causes bodily fluid loss” (Abstract). MPEP 2112.02 II states: “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated.” All of the methods of claims 28-30 are directed to results of the use of composition of claim 1. Thus, the disclosure of Murray et al. of the composition of claim 1 and its administration to a subject is adequate to anticipate the claimed uses of the composition, namely: (i) the hydration composition as enhancing cellular ATP production efficiency to offset dehydration-induced metabolic slowdown (claim 28); (ii) the hydration composition as enhancing evaporative cooling efficiency by dynamically adjusting hydration intake based on core temperature of the subject (claim 29); and (iii) the hydration composition as enhancing cellular glucose absorption via sodium-glucose co-transport mechanisms. MPEP 2112 also discloses that “‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’ Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” Such instruction further supports the determination that the claimed methods based on simply using the prior-art product of Murray et al. as taught in that reference are properly deemed anticipated.
Claims 13, 16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (U.S. 2005/0100637 A1) in view of Wilburn et al. (Wilburn, D., Machek, S., and Ismaeel, A., “Highly Branched Cyclic Dextrin and its Ergogenic Effects in Athletes: A Brief Review,” Journal of Exercise and Nutrition, Volume 4 (Issue 3): 15, 1-8, (2021)) as applied to claims 11 and 19 above, and further in view of Owoc et al. (U.S. 2023/0128454 A1).
Regarding claim 13, Murray et al. discloses the composition as comprising a carbohydrate sweetener ([0062]).
Murray et al. does not disclose the composition as comprising a sweetener from the claimed list.
However, Owoc et al. discloses a similar hydration composition ([0001]) that may comprise a sweetener such as sucralose ([0036]).
It would have been obvious to one having ordinary skill in the art to add sucralose to the composition of Murray et al. Since Murray et al. indicates that the composition may comprise a carbohydrate and provides a list of exemplary suitable carbohydrates, including several that are known to impart sweetness, but indicates that the list is “not limited to” the noted carbohydrates ([0062]), a skilled practitioner would be motivated to consult Owoc et al. for instruction regarding additional suitable components. Since Owoc et al. discloses that the composition may comprise numerous carbohydrates ([0035]) or other sweetener substitutes ([0036]), the inclusion of a sweetener substitute, such as sucralose, would be obvious to a skilled practitioner. MPEP 2144.06 II.
As for claim 16, Owoc et al. discloses such compositions as comprising a mineral that is zinc ([0039]).
As for claim 26, Owoc et al. discloses administration of a rehydration composition to a subject experiencing dehydration due to environmental factors ([0002], [0005]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (U.S. 2005/0100637 A1) and Wilburn et al. (Wilburn, D., Machek, S., and Ismaeel, A., “Highly Branched Cyclic Dextrin and its Ergogenic Effects in Athletes: A Brief Review,” Journal of Exercise and Nutrition, Volume 4 (Issue 3): 15, 1-8, (2021)) as applied to claim 11 above, and further in view of Owoc et al. (U.S. 2023/0128454 A1) and Hitzfelo et al. (U.S. 2010/0028466 A1).
Regarding claim 14, Murray et al. and Wilburn et al. disclose the composition of claim 11.
The cited prior art does not disclose the composition as comprising a colorant from the claimed list.
However, Owoc et al. discloses a similar hydration composition ([0001]) that may comprise a colorant ([0040]). Hitzfelo et al. discloses beta-carotene is a known food colorant ([0002]).
It would have been obvious to one having ordinary skill in the art to incorporate beta-carotene into the composition of Murray et al. First, the combination of Murray et al. with Owoc et al. would be obvious, since they are directed to similar types of beverages and the addition of a colorant as taught in Owoc et al. would be recognized as being to improve consumer acceptance of the composition. Since Owoc et al. indicates that any coloring component may be added but does not disclose specific colorants ([0040]), a skilled practitioner would be motivated to consult Hitzfelo for specific instruction. Since Hitzfelo discloses that beta-carotene is known as a preferred food colorant ([0002]), it would be obvious to add beta-carotene to the composition of Murray et al. as modified by Owoc et al.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (U.S. 2005/0100637 A1) and Wilburn et al. (Wilburn, D., Machek, S., and Ismaeel, A., “Highly Branched Cyclic Dextrin and its Ergogenic Effects in Athletes: A Brief Review,” Journal of Exercise and Nutrition, Volume 4 (Issue 3): 15, 1-8, (2021)) as applied to claim 11 above, and further in view of Owoc et al. (U.S. 2023/0128454 A1) and Stray-Gundersen (U.S. 5,032,411).
Regarding claim 15, Murray et al. and Wilburn et al. disclose the composition of claim 11.
The cited prior art does not disclose the composition as comprising a vitamin from the claimed list.
However, Owoc et al. discloses a similar hydration composition ([0001]) that may comprise a vitamin ([0040]). Stray-Gundersen discloses a similar hydration composition (C4, L55-L61) that may comprise a vitamin that is vitamin C (C9, L20-L22).
It would have been obvious to one having ordinary skill in the art to add vitamin C to the composition of Murray et al. First, the combination of Murray et al. with Owoc et al. would be obvious, since they are directed to similar types of beverages and the addition of a vitamin as taught in Owoc et al. would be recognized as being to impart nutritional functionality to the composition. Since Owoc et al. indicates that any vitamin component may be added but does not disclose specific vitamins ([0040]), a skilled practitioner would be motivated to consult Stray-Gunderson for specific instruction. Since Stray-Gunderson discloses that vitamin C is known as a vitamin suited for a beverage (C9, L20-L22), it would be obvious to add vitamin C to the composition of Murray et al. as modified by Owoc et al.
Response to Arguments
Claim Rejections - 35 U.S.C. § 112: Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 3 based on amendment to the claim. Accordingly, the 35 U.S.C. § 112(b) rejection has been withdrawn.
Claim Rejections - 35 U.S.C. § 103 of claims 1, 2, 4-12, 17-25, and 27-30 over Murray et al.: Applicant’s arguments (Applicant’s Remarks, p. 8, ¶2 – p. 11, ¶1) have been fully considered and are persuasive to the extent that the claims as presently amended would not be obvious in view of Murray et al. However, upon further consideration, new grounds of rejection are made in view of Murray et al. combined with Wilburn et al.
Regarding the secondary considerations, Applicant first argued that no compositional information for comparative products recorded in Figure 1 of the Gillitt Declaration filed 11/26/2025 should be necessary for the asserted results to be commensurate in scope with the claims (Applicant’s Remarks, p. 11, ¶2-¶3).
However, paragraph 65 of the Non-Final Office Action filed 02/20/2026 stated: “The data in Figure 1 is of no persuasive value due to lacking any explanation as to the composition of the comparative products or the ‘current embodiment’ in terms of what the carbohydrate mixture is and what concentrations of carbohydrates are present.” There lack of any description of the compositions for the data points—including for the “current embodiment”—render the data essentially useless. There is no basis for determining whether the asserted unexpected results would occur over the entire scope of the present claims, e.g., all types of polymeric dextrins that fall within the scope of claim 1, all possible concentrations of each respective carbohydrates that fall within the scope of claim 1, or beverages comprising components other than carbohydrates that would still affect osmolality. For the data to be of any persuasive value, at least the “current embodiment” would need to be defined in terms of its composition, as well as additional embodiments as required by MPEP 716.02(d) II (“To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.”).
Applicant then argued that the osmolality and concentration boundaries are derived from various guidelines (Applicant’s Remarks, p. 11, ¶2, ¶4).
Applicant’s clarifications are noted but are insufficient to overcome the present claim rejections on the basis of an assertion of unexpected results due to other deficiencies in the assertion noted above.
Applicant next argued that blending of products does not simply result in averaging of osmolality (Applicant’s Remarks, p. 11, ¶2, ¶5 – p. 12, ¶1).
Applicant’s argument is moot in light of the updated claim rejection that relies on incorporating HBCD into the composition of Murray et al.
Applicant then again asserted a long-felt need as evidence of non-obviousness on the basis of a large manufacturer producing multiple product lines (Applicant’s Remarks, p. 12, ¶2).
Examiner maintains that the assertion is insufficient for the reasons detailed in paragraph 65 of the Non-Final Office Action filed 02/20/2026. Applicant’s argument is further weakened by the present claim rejections that additionally rely on Wilburn et al.
Regarding claims 29, Applicant argued that the claim limitation requiring “enhancing evaporative cooling efficiency by dynamically adjusting hydration intake based on core temperature of the subject” implicitly requires “an active, ongoing behavioral protocol, monitoring a subject’s core temperature and adjusting intake accordingly, that requires real-time physiological measurement and responsive dosing decisions” (Applicant’s Remarks, p. 12, ¶5).
However, Applicant’s asserted interpretation of the limitation of claim 29 is much narrower than what is actually claimed. The limitation stating “based on core temperature of the subject” does not require external monitoring in the form of “real-time physiological measurement”. It would include a subject simply realizing they are hot and drinking more of the beverage. Examiner maintains that the claim is properly rejected.
Claim Rejections - 35 U.S.C. § 103 of claim 3 over Murray et al. and Szente; claims 13, 16, and 26 over Murray and Owoc et al.; claim 14 over Murray et al., Owoc et al., and Hitzfelo et al.; claim 15 over Murray et al., Owoc et al., and Stray-Gundersen:
Applicant asserted patentability on the basis of dependence from claim 1 (Applicant’s Remarks, p. 13, ¶2 – p. 14, ¶1).
The rejection of claim 1 has been updated herein, and the rejections of the dependent claims have been updated and maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claims 1-30 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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