DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed December 4, 2025 has been entered. Claim 37 is new. Claims 20-26 and 28-37 are pending.
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 20-26 and 28-36 are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al. (US 2013/0045297).
Regarding claims 20-24 and 30-36, Knight discloses a method of treating or preventing hydration in a human subject the method comprising; (a) administering orally to a human subject a liquid electrolyte composition having a pH in the range of about 3 to about 7 wherein the liquid electrolyte composition comprises: (i) 0.05 wt% Acacia gum; (ii) about 0.1 wt% to about 1 wt% sodium citrate; (iii) about 0.02 wt% to about 0.10 wt% tripotassium citrate monohydrate; (iv) about 0.1 wt% to about 1.2 wt% sodium chloride; (v) about 0.05 wt% to about 0.25 wt% potassium chloride; (vii) about 0.08 wt% to about 0.5 wt% calcium chloride; (viii) about 10 to about 60 mEq/L citrate in the form of citric acid (i.e., about 0.64 g/L to about 3.8 g/L; (viv) about 0.006 to about 0.24 g/L magnesium wherein the sour of magnesium is magnesium chloride, magnesium carbonate, magnesium acetate, magnesium oxide, magnesium citrate, magnesium diphosphate, or magnesium triphosphate; and (x) about 0.7 wt% to about 20 wt% carbohydrates including dextrose, fructose, sucrose, maltose, maltodextrin, galactose, trehalose, fructo-oligosaccharides, beta-glucan, trioses, and combinations thereof ([0011],[0024],[0034]-[0041]). Knight also discloses the liquid electrolyte composition may comprise about 0.0006 wt% to about 0.06 wt% of one or more sugar substitutes including sucralose, saccharin, aspartame, acesulfame potassium, stevia, neotame and combinations thereof ([0041]).
Claimed (claims 20 and 35)
Knight ([0018]-[0023])
Potassium (g/L)
4 - 8
0.16-1.75
Chloride (g/L)
3.5-7.5
0.35 – 2.1
Sodium (g/L)
0-0.5
0.11-2.3
Citric acid (g/L)
1-2.5
0.64-3.8
Magnesium (g/L)
0.05-0.45
.006-0.24
Here, Knight discloses amounts of potassium that satisfy the requirement the potassium is present in the range of about 45% to about 55% of the total dry weight of the potassium and the chloride in the electrolyte composition and wherein the quantity of potassium accounts for at least about 40% to about 55% of the total dry weight of the electrolytes in the electrolyte composition.
Knight discloses dehydration can have serious effects, including muscle cramps ([0002], [0019]). Knight discloses treatment or prevention of dehydration usually involved intake of necessary water and electrolytes ([0004]).
Knight discloses the presence of a sufficient levels of potassium in an electrolyte formulation may provide nutritional benefits in addition to the hydration benefits ([0019]). For example, Knight discloses a potassium deficiency may results in muscular cramping and the presence of potassium at a concentration more than about 20 meq/L may contribute to the alleviation of muscular cramping ([0019]). Therefore, given Knight discloses administering a liquid electrolyte composition with potassium in an amount known to contribute to the alleviation of muscular cramping, it necessarily follows that one of ordinary skill in the art would be able to determine based on routine experimentation an amount and dosing intervals sufficient to alleviate muscular cramping within 5 minutes or less.
Knight does not disclose the claimed amount of potassium or chloride.
However, given Knight discloses administering a liquid electrolyte composition with potassium in an amount known to contribute to the alleviation of muscular cramping, one of ordinary skill in the art would be motivated to add more potassium or administer more than one dose of potassium to obtain better or optimized relief of muscular cramping. Moreover, given Knight discloses a liquid electrolyte composition comprising potassium, sodium, chloride and magnesium in amounts known to contribute to the alleviation of dehydration and thus muscular cramping, it is clear that adding more chloride would not change the efficiency of the composition, for example adding more potassium chloride to increase potassium content.
Regarding claim 25, Knight discloses all of the claim limitations as set forth above. Given Knight disclose alleviating muscular cramping generally, the person of ordinary skill in the art would understand that the type of cramping could include any type of muscle cramp including leg, foot or menstrual.
Regarding claim 26, Knight discloses all of the claim limitations as set forth above. Given Knight disclose alleviating muscular cramping generally, the person of ordinary skill in the art would understand that this alleviation would including reducing the duration or severity of the muscle cramp.
Regarding claims 28 and 29, Knight discloses all of the claim limitations as set forth above. Knight discloses the efficacy of the liquid electrolyte composition when administered to geriatric human subjects ([0084], claim 35).
Given Knight discloses geriatric subjects generally, it necessarily follows that the human subject could be a female.
Allowable Subject Matter
Claim 39 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Knight discloses an electrolyte formulation requiring a source of calcium ion (Abstract, [0005], [0007], [0020]). There is no motivation to remove calcium from the composition of Knight.
Response to Amendment
The Declarations under 37 CFR 1.132 originally filed December 2, 2019 and December 9, 2020 in US Application No. 15/625,993 and resubmitted December 4, 2025 in the present application are insufficient to overcome the rejection of claims 20-36 based upon Knight (US 20130045297) as set forth in the last Office action.
Mark Matlock Declaration-
Declarant explains “[t]he major obstacle with producing a high potassium product that is suitable for consumption has been overcoming the negative organoleptic properties of potassium. Specifically, potassium produces a metallic taste that makes it unusable at quantities that would be ideal for products intended for dietary consumption” (paragraph 8). Declarant submit “the present patent application has overcome the challenges outlined above and has produced consumable, high potassium compositions as outlined in the pending claims that have an acceptable organoleptic profile” (paragraph 9).
In this case, there is no evidence on the record that demonstrates the composition of Knight, when adjusted to have increased potassium content, would exhibit inferior sensory properties to the presently claimed composition.
Eric J. Murphy Declaration-
Declarant submits he “attest to the unexpected results observed in subjects who consume composition within the scope of the pending claims” (paragraph 4). Declarant submits “we have demonstrated that the claimed consumable electrolyte compositions can rapidly alleviate cramps with surprising efficacy” (paragraph 4).
There is no evidence on the record that compares the claimed composition to the composition of Knight. It is not clear that the composition of Knight would not be effective at alleviating cramps in a subject. Moreover, given Knight teaches a composition comprising potassium that reports alleviating cramps, it is not clear that it is unexpected that increasing the concentration of potassium would improve the efficacy of the composition.
Declarant comments he has “heard from numerous athletic trains who were surprised and amazed at how effective the claimed products were at mitigating cramps in consumers during athletic performance.”
Here there is not evidence that the product of Knight would not exhibit the same efficacy as the claimed composition.
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive.
Applicant submit “[b]ecause the liquid electrolyte composition of Knight contains about 0.08 wt% to about 0.5 wt% calcium chloride . . . the liquid electrolyte composition of Knight cannot reasonably be interpreted as describing the recited electrolyte composition in which the chloride is in the range of about 3.5 g/L to about 7.5 g/L where the source of chloride consists of potassium chloride and sodium chloride.”
Here, claim 20 requires a electrolyte composition comprising potassium, chloride, sodium, citric acid and a sweetener. The term “comprising” is open ended an allows for additional ingredients in the electrolyte composition. Here, chloride in the range of 3.5 g/L to about 7.5 g/L must come from potassium chloride and sodium chloride. The claim does not limit additional amounts of chloride from other sources. Even if claim 20 excludes calcium chloride, the invention of night does not require calcium chloride. Knight disclose the chloride ion used in the invention can come from various sources including sodium chloride, potassium chloride, calcium chloride, magnesium chloride and combinations thereof ([0021]).
Applicant is directed to the rejection set forth above which clearly acknowledges Knight does not disclose the claimed amount of potassium or chloride.
Note, given Knight discloses administering a liquid electrolyte composition with potassium in an amount known to contribute to the alleviation of muscular cramping, one of ordinary skill in the art would be motivated to add more potassium or administer more than one dose of potassium to obtain better or optimized relief of muscular cramping. Moreover, given Knight discloses a liquid electrolyte composition comprising potassium, sodium, chloride and magnesium in amounts known to contribute to the alleviation of dehydration and thus muscular cramping, it is clear that adding more chloride would not change the efficiency of the composition, for example adding more potassium chloride to increase potassium content.
Applicant submits “Knight trends more towards leading one skilled in the art away from the claimed subject matter” Applicant notes paragraph [0039] which teaches that potassium chloride and sodium chloride contribute to the saltiness and/or bitterness of the electrolyte composition.
While Knight acknowledges the taste attributes of sodium chloride and potassium chloride, the reference does not disclose ranges where the composition becomes inferior or not palatable. Moreover, while the rejection set forth above suggest increasing potassium content, potassium content can be increased by adding other potassium salts, e.g., potassium citrate.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759