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 .
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/8/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 12 recite a composition which includes “ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract and ginger root extract. Claim 18 recites “ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract and ginger root extract” and the amount of ampelopsis grossedentata extract (minimum 98% dihydromyricetin) is an effective amount for counteracting intoxicating effects. Dependent claim 8 further includes monk fruit extract. The instant invention is directed to extracts and their used for counteracting effects of alcohol-containing beverages and food products. However, which extracts that are in possession and how they are obtained is not detailed. With respect to ampelopsis grossedentata extract, the specification discloses DHM stands for dihydromyricetin, a component derived from the ampelopsis grossedentata plant [0026-27]. With respect to milk thistle extract, the specification describes milk thistle extract as being rich in silymarin, however, the specification does not indicate what other components are found in milk thistle extracts [0034]. With respect to prickly pear cactus extract, the specification does not indicate what components are extracted from prickly pear cactus which synergistically interact with milk thistle extract to enhance liver function, support detoxification and reduce hangover symptoms [0035]. Additionally, with respect to ginger root extract, the specification does not indicate what components are extracted from ginger root which have anti-inflammatory properties, antioxidant properties and reduce hangover symptoms [0037]. The extracts of monk fruit are also not identified in the specification [0067].
Specific compounds in the prior art disclose silibinin is the active ingredient of the silymarin constituent of milk thistle, which would meet the written description and enablement provisions of 35 USC 112, first paragraph (Powell, US 2015/0342923, [0026]). However, the instant claims are directed to encompass all components in milk thistle extract, ampelopsis grossedentata extract, prickly pear extract, ginger root extract and monk fruit extract. The term extracts does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are or composed of and how these extracts interact to counteract the effects of alcohol. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that: The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed chemical structures indicated in the prior art, the skilled artisan cannot envision the detailed chemical structure of the encompassed extracts, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993)
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
Therefore the instant claims do not meet the written description provision of 35 USC § 112, first paragraph. The chemical species encompassed by the word extract results in a genus that is highly variant as different isolation methods can lead to isolation of different species and applicant has not indicated what identifying characteristics are associated with the extracts.
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.
Claims 1-20 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.
Claims 1, 12 and 18 recite “liver detoxification compounds” which is indefinite. The metes and bounds of which compounds have liver detoxification properties cannot be deciphered. Additionally, the claim recites a gummy composition comprising ‘electrolytes; vitamin B complexes; liver detoxification compounds;” which renders the claim unclear because the colon is not followed by “and” with a final component. It appears that the composition further includes ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract, ginger root extract and L-alanyl-L-glutamine, however the specification appears to teach that the liver detoxification compounds and the extracts listed are the same compounds [0015]. If this is the case the claim lacks clarity by defining ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract, ginger root extract and L-alanyl-L-glutamine as the liver detoxification compounds. Furthermore, the extracts of are unclear because the specification does not detail what compounds possessed in the extracts of ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract and ginger root extract that counteract the effects of alcohol. Therefore, the metes and bounds of the extracts claimed cannot be deciphered. Claims 2-11, 13-17, 19 and 20 are rejected for depending on these claims.
Claims 1, 10, 12, 17 and 18 recite “ampelopsis grossedentata extract (DHM)” and “ampelopsis grossedentata extract (minimum 98% dihydromyricetin)”, respectively, which are indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1, 10, 12 and 17 recite the broad recitation ampelopsis grossedentata extract, and the claim also recites (DHM), which is an abbreviation for the compound dihydromyricetin, which is the narrower statement of the range/limitation. In the present instance, claim 18 recites the broad recitation ampelopsis grossedentata extract, and the claim also recites (minimum 98% dihydromyricetin), which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 10 and 17 recite “Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (methylcobalamin), Calcium (Calcium Phosphate), Magnesium (as citrate) and Potassium (as Citrate)” and claim 10 further includes “prickly pear cactus (Opuntia ficus-indica) extract, Milk Thistle (Silybum marianum) seed Extract and Ginger Root (Zingiber officinale) extract which are indefinite for reciting a broad and narrow statement, within the parentheses in the same claim. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purpose of compact prosecution the limitations in the parentheses have not been treated as further limiting to the claims.
Claims 2, 4, 8, 10, 13, 14 and 17 recites improper Markush claims which render the claims indefinite. Claims 2 and 13 recite “the electrolytes include one or more combinations of: calcium, magnesium, potassium, phosphorous, sodium, and chloride”. Claim 4 and 14 recite “wherein the Vitamin B complexes include one or combinations of: B6 and B12”. Claim 8 recites “includes one or combinations of: allulose syrup, erythritol, sucrose, apple juice, natural flavors, citric acid, sodium hydrogen malate, monk fruit extract, stevia, and Himalayan salt”. Claims 10 and 17 recite “the compositions includes on or more of the following ranges: Ampelopsis grossedentata extract (DHM) 200-450 mg, …L-alanyl-L-glutamine 40-60 mg”. All the groups recite the Markush group ‘includes’ or ‘comprises’ the listed members. However, a Markush claim requires the members are selected from a closed group “consisting of” the alternative members. (See MPEP 2117). Therefore, the Markush groupings are improper and indefinite.
Claim 10 recites the limitation " Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (methylcobalamin), Calcium (Calcium Phosphate), Magnesium (as citrate), Potassium (as citrate), Phosphorous (Calcium Phosphate), Sodium (as sodium citrate) and Chloride (as sodium chloride)" in reference to the composition of claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation " Vitamin B6 (Pyridoxine Hydrochloride), Vitamin B12 (methylcobalamin), Calcium (Calcium Phosphate), Magnesium (as citrate) and Potassium (as citrate)" in reference to the composition of claim 12. There is insufficient antecedent basis for this limitation in the claim.
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).
Applicant claims a nutraceutical gummy composition comprising electrolytes, vitamin B complexes, liver detoxification compounds including ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract, ginger root extract and L-alanyl-L-glutamine. (Claim 1)
Applicant claims a nutraceutical gummy composition comprising electrolytes, vitamin B complexes, liver detoxification compounds including ampelopsis grossedentata extract (DHM), prickly pear cactus extract, milk thistle extract, ginger root extract and L-alanyl-L-glutamine, 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, ginger root extract and L-alanyl-L-glutamine, wherein the amount of ampelopsis grossedentata extract is effective for counteracting intoxicating effects. (Claim 18)
With respect to claims 1-5, 7-11, 18 and 20, 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 claim 1 and 18 Thorsby et al. do not teach dihydromyricetin and ginger root extract. 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 1, 12 and 18 Thorsby et al. and Powell do not teach L-alanyl-L-glutamine. With respect to claims 6, 12-17 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 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]. 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. 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].
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. Therefore, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell and Traylor and 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 and Traylor and 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.
It would have been prima facie obvious to combine the teachings of Thorsby et al., Powell and Traylor 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.
Additionally, it would have been prima facie obvious to combine the teachings of Thorsby et al., Powell and Traylor and include a gummy base and coating comprising food coloring, citrus pectin, 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 filing to include food coloring, citrus pectin, water, safflower oil and carnauba wax because Traylor teaches a semi-solid gummy product which is formed from a solution of food coloring, citrus pectin, oil which includes safflower oil for enrichment and carnauba wax and 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.
Conclusion
No claims allowed.
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/BETHANY P BARHAM/ Supervisory Patent Examiner, Art Unit 1611