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 .
Applicants amendment filed 4/17/2026 has been entered. Claims 1, 2, 4, 6-8, 10-20 were amended. Claims 1-20 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 4/17/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn.
Claim Objections
Applicant is advised that should claim 1 (along with dependent claims 2, 4, 6, 10 and 11) be found allowable, claim 12 (along with dependent claims 13-17) will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant’s amendment has necessitated a new rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thorsby et al. (US 2011/0217392; published September 8, 2011) in view of Powell (US 2015/0342923; published December 3, 2015) and Traylor (US 2016/0015777; published January 21, 2016) and Kuramoto et al. (JP 4285413; granted April 3, 2009).
Applicant claims a nutraceutical gummy composition comprising electrolytes, vitamin B complexes, liver detoxification compounds comprising ampelopsis grossedentata extract, prickly pear cactus extract, milk thistle extract and ginger root extract; a gummy base comprising citrus pectin and water and a coating comprising wax. (Claims 1 and 12)
Applicant claims a nutraceutical gummy composition comprising electrolytes, vitamin B complexes, liver detoxification compounds including ampelopsis grossedentata extract, prickly pear cactus extract, milk thistle extract and ginger root extract, a gummy base comprising citrus pectin and water and a coating comprising oil and wax. (Claim 12)
Applicant claims a method of treating effects of alcohol-containing beverages and solid food products in a subject comprising causing the subject to consume a nutraceutical gummy composition comprising electrolytes, vitamin B complexes, liver detoxification compounds including ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract and ginger root extract, wherein ampelopsis grossedentata extract comprises a minimum of 98% dihydromyricetin that is effective for counteracting intoxicating effects. (Claim 18)
With respect to claims 1-10, 12-15 and 16-19, Thorsby et al. teach compositions and a method for countering the effects of alcohol consumption by orally administering a composition comprising various vitamins, potassium (electrolyte), magnesium (electrolytes), milk thistle extract, amino acids, green tea extract, prickly pear extract, malic acid and optionally maqui berry extract and various additives for flavor and preservatives (abstract). The compositions are administered as a liquid but can also be pre-added to solid forms, including gummies by coating the dose on the solid form or mixing it into food prior to its final formation [0009]. The amino acids include L-alanine and L-glutamine, the prickly pear extract is from cactus Opuntia ficus-indica, milk thistle is from the seeds of Silybum Adans, which is known for liver protection as well as vitamin B6 and vitamin B12 [0015-38]. Additives include natural flavors and no sugar sweeteners such as stevia and lo han (monk fruit) [0042-43]. The formulations primarily comprise 1-3 mg vitamin B6, 2 mcg-1 mg vitamin B12, 50-100 mg potassium, 10-25 mg magnesium, 25-200 mg milk thistle extract, 50-100 mg L-glutamine, 50-100 mg L-alanine, 40-100 mg prickly pear extract [0052-60].
With respect to claims 1, 12 and 18 Thorsby et al. do not teach ginger root extract. With respect to claims 1, 12 and 19 Thorsby et al. do not a gummy base comprising citrus pectin and water and a coating comprising wax With respect to claims 2, 10, 13 and 17, Thorsby et al. do not teach phosphorous, sodium or chloride electrolytes. With respect to claim 18 Thorsby et al. do not teach dihydromyricetin. It is for this reason that Powell is joined.
Powell teach compositions and methods of recovering from alcohol consumption comprising administering compositions comprising dihydromyricetin (DHM), prickly pear extract, milk thistle, ginger root, Vitamin B, electrolytes and/or sugars (abstract). The compositions are capable of treating multiple symptoms of hangovers, can be used to aid in sobering up if taken during drinking, taken before drinking to keep them sober or used as a daily supplement to replenish electrolytes [0009]. DHM increases the rate at which alcohol and acetaldehyde are removed by the liver and reduce the negative effects of alcohol on the brain, such as disruption of sleep to prevent hangovers [0022]. The amount of DHM that is effective ranges from between 300-3600 mg [0023]. The composition can be incorporated into any variety of delivery systems along with food coloring [0024]. The amount of prickly pear extract ranges from 50-1500 mg [0025]. An exemplary capsule composition comprises 300 mg DHM, 50 mg prickly pear extract and 75 mg of milk thistle [0026]. The formulations can further add 25-1500 mg ginger root extract which combats gastrointestinal disturbances [0027]. The compositions can further include vitamin B complex to replenish vitamins lost with drinking alcohol in a range of 25-400 mg with additional vitamin C and vitamin E [0029]. Electrolytes can include a mixture of sodium, potassium, chloride, calcium, magnesium and sodium chloride in an amount ranging from 50-800 mg [0029]. The composition may be in the form of a powder or other solid form [0034]. The addition of sugars or other carbohydrates in the formulations excipients is also taught [0029-0041].
With respect to claim 11, 16 and 20 Thorsby et al. and Powell do not teach L-alanyl-L-glutamine. With respect to claims 1, 6, 15 and 19, Thorsby et al. and Powell do not teach the gummy formulation comprises a gummy base comprising citrus pectin and water and a coating comprising oil, preferably safflower oil and wax, preferably carnauba. It is for this reason that Traylor and Kuramoto is joined.
Traylor teaches a protein delivery system that provides amino acids to stimulate muscle growth and maintain muscle mass (abstract). The formulations promote overall health by improving physical well-being [0084]. The proteins increase performance and have various health benefits [0086]. The most abundant amino acid in the body is L-alanyl-L-glutamine and is converted to glucose when energy expenditure increases, it aids in clearing ammonia in the bloodstream, provides fuel to the immune system and decreases illness in endurance athletes due to prolonged exercise and increased risk of infection from immunosuppression [0111]. The formulation is enriched by other compounds including green tea, safflower oils, vitamin B6, vitamin B12 and ginger (zingiber officinale) [0118]. The preferred form is a semi-solid gummy product which may include food coloring, citric acid, gelatin, sugar, glucose syrup, starch and flavoring [0124]. The gummy mixture includes a solution comprising sweeteners, oil and carnauba wax [0127]. Traylor teaches that the protein source include artificial sweeteners, such as erythritol, xylitol, citrus pectin, stevia and sucrose [0133]. The preferred protein source is L-alanyl-L-glutamine in the range of 1-50 grams per serving [0134]. The gummy candy is a convenient delivery system as opposed to drinks and powders since the consumption of high amounts of sugar and sucrose is not recommended [0137]. The semi-solid is preferred over a powder because it reduces the risk of bacterial contamination [0151]. The resulting gummy matrix has a water content of 8-21% [0173]. Although the description of the gummy does not detail the base and coating as separate one of ordinary skill in the art would expect the oil and wax to act as a coating to prevent individual gummies from sticking to each other. It is for this reason that Kuramoto is joined.
Kuramoto teach methods of making gummy candies which prevent migration of the moisture in the gummy matrix to the sugar-coated surface [0007]. Providing a oil layer as an intermediate layer prevents migration of the moisture to the sugar layer and functional components in the gummy [0011]. The second layer comprises oil selected from safflower oil [0017].
Thorsby et al., Powell and Traylor all teach formulations comprising amino acids and Vitamin B complexes for improving well-being and health in a patient. Thorsby et al., Traylor and Kuramoto all teach gummy formulations. Therefore, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell, Traylor and Kuramoto to include dihydromyricetin with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include dihydromyricetin because Powell teaches adding dihydromyricetin increases the rate at which alcohol and acetaldehyde are removed by the liver and reduce the negative effects of alcohol on the brain.
It would have been prima facie obvious to combine the teachings of Thorsby et al., Powell, Traylor and Kuramoto to include ginger root extract with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include ginger root extract because Powell teaches adding 25-1500 mg ginger root extract combats gastrointestinal disturbances which would aid in improving patient health.
Additionally, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell, Traylor and Kuramoto to include a gummy base comprising citrus pectin and water, safflower oil and carnauba wax with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filling to include citrus pectin and water because Traylor teaches a semi-solid gummy product which is formed from a solution of citrus pectin so that the gummy matrix has a water content of 8-21%. One of ordinary skill in the art would expect the safflower oil and carnauba wax to act as a coating to prevent individual gummies from sticking to each other. Additionally, the semi-solid gummy form reduces the risk of bacterial contamination when compared to powder formulations and the water content would aid in hydrating the patient.
Additionally, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell, Traylor and Kuramoto to further include a coating comprising safflower oil and carnauba wax with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filling to a coating comprising safflower oil and carnauba wax because Traylor teaches a semi-solid a gummy product citrus pectin and includes safflower oil for enrichment with carnauba wax and the gummy matrix has a water content of 8-21% and Kuramoto teach applying an safflower oil coating layer prevents migration of the moisture and functional components of the gummy matrix.
With respect to claims 11, 16 and 20, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell, Traylor and Kuramoto and include L-alanyl-L-glutamine with a reasonable expectation of success. One of ordinary skill in the art would have been motivated before the time of filing to include L-alanyl-L-glutamine as a protein because Traylor teaches L-alanyl-L-glutamine aids in clearing ammonia in the bloodstream and provides fuel to the immune system to decreases risk of illness.
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive. Applicant first argues that Traylor teaches the opposite of a separate coating layer and does not teach or suggest applying a coating to the exterior of the finished gummy product. The Examiner is not persuaded by this argument because Kuramoto teach applying a safflower oil coating layer prevents migration of the moisture and functional components of the gummy matrix. Therefore, coating a gummy with safflower oil to prevent moisture migration would have been prima facie obvious to one of ordinary skill in the art before the time of filing.
Applicant further argues Traylor never teaches using citrus pectin as a structural gelling agent for a gummy base. The Examiner is not persuaded by this argument. Traylor teach that the preferred form is a semi-solid gummy product which may include food coloring, citric acid, gelatin, sugar, glucose syrup, starch and flavoring [0124]. Furthermore, Kuramoto teaches that providing an oil layer as an intermediate layer prevents migration of the moisture to the sugar layer and functional components in the gummy [0011]. Traylor teaches that combining oil and carnauba wax together [0127]. Therefore, mixing safflower oil with carnuba wax to form a coating to prevent moisture migration would have been prima facie obvious.
Applicant further argues that the minimum of 98% dihydromyricetin is not taught by Powell because Powell teaches DHM in amounts of 300-3600 mg without specifying purity. The Examiner is not persuaded by this argument because Powell teach DHM is a compound found in vine tea extract [0022] therefore the 100% pure compound is disclosed in the teachings of Powell. Therefore the ampelopsis grossedentata extract DHM is taught by Powell.
Finally Applicant argues Traylor does not teach the alcohol specific function. The Examiner is not persuaded by this argument because the rejection is based on the teachings of Thorsby et al., Powell, Traylor and Kuramoto and Powell DHM (ampelopsin) is known to reduce the negative effects of alcohol [0022].. Therefore, the rejection has been maintained.
Conclusion
No claims allowed.
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 DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617
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