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 is acknowledged of the amendment and response filed 2/9/2026. Claims 1 and 3-10 are pending in the application.
Claim Objections
Claim 1 recites (80% ZN). Correction (Zn) is needed. ZN is interpreted as Zinc in examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a formulation that has organic apple cider vinegar powder comprising 3-8% acetic acid wherein the amount of acetic acid is in the range of 313mg-940mg; and 250mg-750mg sodium diacetate. At 3-8% acetic acid, the amount of ACV powder (8% acetic acid) needed to provide the claimed amount of acetic acid is 3.9g -11.8g. The ratio of ACV to sodium diacetate in the claimed composition, therefore does not meet the limitation of a 1:1 ratio. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
Further, Claim 8 recites a use without a corresponding method of use, rendering the claim indefinite.
Claims 1 and 3-10 are rejected under 35 USC 103 as being unpatentable over the following identified product the supplement facts for which appear on the archived Bragg Product Webpage dated 9/22/2021, retrieved on 10/24/2025
https://web.archive.org/web/20210922202643/https://www.bragg.com/collections/acv-supplement/products/acv-supplement
Regarding claim 1 Bragg discloses a nutritional supplement, (self-defined by the presence of known nutrients in the supplement facts) that has a serving size of 3 vegan capsules configured to deliver a dose of at least 500mg of acetic acid (750mg). The phrase “per day” merely describes an intended dosage regimen and does not impart a structural limitation to the composition. The “nutritional supplement” itself remains defined by the components and amounts, in solid form, independent of any administration schedule.
The units of weight presented are consistent with a powder. A press release dated June 24, 2021 (https://www.prnewswire.com/news-releases/bragg-introduces-apple-cider-vinegar-supplement-and-appointment-of-scientific-advisory-board-301318955.html) confirms the powder form:
“Bragg's new supplement takes their century-long commitment one step further, with the first supplement in the U.S. that provides the scientifically proven dosage of 750 milligrams (mgs) of acetic acid -- the equivalent to 1 tablespoon of liquid ACV -- to deliver upon all the benefits that ACV has to offer. Benefits from the consumption of 750 mg. of acetic acid, or three Bragg ACV capsules, include helping control appetite and managing weight gain, and helping maintain healthy blood glucose and cholesterol levels. In addition, Vitamin D and Zinc support immunity.”
The claimed formulation has organic apple cider vinegar powder comprising 3-8% acetic acid wherein the amount of acetic acid is in the range of 313mg-940mg; and 250mg-750mg sodium diacetate. At 3-8% acetic acid, the amount of ACV powder (8% acetic acid) needed to provide the claimed amount of acetic acid is 3.9g -11.8g. The ratio of ACV to sodium diacetate in the claimed composition, therefore does not meet the limitation of a 1:1 ratio.
The reference supplement has 1877mg of proprietary apple cider vinegar +sodium diacetate and provides 750mg of acetic acid, in the claimed range. The supplement has 150mg sodium from diacetate. This corresponds to about 926 mg of sodium diacetate (corrected-the previous Office action indicated 888mg), providing about 392 mg acetic acid.
By difference, the amount of apple cider vinegar powder in the proprietary blend is about 951mg, corresponding to a ratio of ACV powder to sodium diacetate of about 1:1, as claimed.
Applicant has not shown the criticality of the specific range of sodium diacetate (250-750mg). As explained above, the claimed ratio of ACV: sodium diacetate is not met by the claimed amounts.
It would have been obvious to one of ordinary skill in the art to combine ACV with sodium diacetate in optimal proportions, because sodium diacetate was well known as a stable, dry source of acetic acid and acetate functionally suitable for use in food and ingestible compositions. It is known that sodium diacetate is a complex acetate salt containing combined but undissociated acetic acid, and such compositions are relatively stable in shipping, storage and use as dry vinegar substitutes and food additives. Sodium diacetate is further recognized as a crystalline complex of sodium acetate and acetic acid that provides concentrated acetic acid functionality in a stable, dry form. One of ordinary skill in the art would have also known that sodium acetate and acetic acid are conventionally used together as pH -buffering systems for maintaining mildly acidic conditions. Accordingly, one of ordinary skill in the art would have been motivated to blend ACV powder with sodium diacetate in amounts sufficient to achieve a desired acetic acid delivery profile within practical capsule fill limits, while reducing excessive acidity, improving gastrointestinal tolerability, and enhancing stability, with a reasonable expectation of success.
The claimed formulation has a powder configured to deliver at least 500mg acetic acid per dose with 100,000 IU of vitamin D3. The reference supplement has 1200 IU of Vitamin D3 per dose. One of ordinary skill in the art would have added sufficient vitamin D3 to obtain a targeted percentage of daily value of supplemental vitamin D in a dose, with a reasonable expectation of success
The claimed formulation has Zinc Oxide (80% Zn) powder 4.3mg-13mg. The supplement has 13mg of Zn from Zinc oxide.
The vegan capsule of supplement containing the powder has silica (silicon dioxide) and pea starch as claimed.
Regarding claim 3 and 5, the acetate salt in the supplement is sodium diacetate, comprising sodium as claimed.
Regarding claim 4 and 6, the supplement does not disclose an acetate salt comprising potassium/di-potassium. However, the substitution of sodium salts with potassium salts is well-known in the art of foods and nutritional supplements, primarily for the purpose of limiting daily dietary sodium levels. Therefore the substitution of a sodium salt with a potassium salt in the claimed formulation for known health benefits, is an obvious modification of the art.
Regarding claim 7, the supplement is in the form of a capsule which by definition includes a solid two piece hard shell or soft gel capsule in standard pharmaceutical practice.
Regarding claim 8, the supplement is described in the press release as above, for delivering up to 750mg of acetic acid for targeted health benefits, encompassing the claimed range.
Regarding claim 9, the supplement provides an ingested dose of 3 capsules providing a scientifically validated dose.
Regarding claim 10, the nutritional supplement has zinc, sodium and vitamin D3 representative of vitamins and minerals. One of ordinary skill in the art would add other vitamins, minerals, herbal extracts (ashwagandha) to the dry composition with a reasonable expectation of successfully providing a stable supplement composition with desired nutritional functionality, the health benefits of each of these ingredients, in stress and immunity support, for example, being well known.
Claims 1 and 3-10 are therefore prima facie obvious in view of the art.
Response to Arguments
Claim amendments render the previous rejections under 35USC112(b) and 35 USC 103 moot. However, the amended claims present new grounds for rejection. The previously cited reference is maintained, for the reasons discussed in the current Office action.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
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