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 .
Claim Status
Claims 1 – 25 are examined here-in.
Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 should include the word “in” between “is” and “an”. For example, “The beverage composition of claim 7, wherein the cannabinoid is in an amount of from about 1 mg to about 20 mg.”
Appropriate correction is required.
Rejections of “Use” Claims - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 19, 20, and 21 are directed to non-statutory subject matter. The claims does not fall within at least one of the four categories of patent eligible subject matter because "use of the beverage composition" is not a process, machine, manufacture, or composition of matter. According to MPEP 2173.05(q), “use” claims that merely recite a use without any active, positive steps delimiting how this use is actually practiced do not fall into one of the four categories of patent eligible subject matter.
Rejections of “Use” Claims - 35 USC § 112(b)
Claims 19, 20, and 21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. These claims are written as “use of the beverage composition” (claims 19, 20, 21) which is indefinite because it merely recites a use without any active, positive steps delimiting how the use is practiced.
For compact prosecution, claims 19, 20, and 21 will be examined as methods claims.
Notably: As methods claims, claims 19 – 21 may be substantial duplicates of claims 22, 24, and 25. Claims that are substantial duplicates will be objected to under 37 CFR 1.75, because 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).
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.
Claims 20 and 24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
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 20 and 24 recites the broad recitation “cancer”, followed by “e.g. rectal adenomas”, which is the narrower statement of the limitation. The claims 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.
Further regarding claims 20 and 24, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 15, 17 - 19, 22, and 23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Antelis (US 2020/0306290 A1).
Antelis teaches a beverage composition that includes hibiscus that is effective for lowering blood pressure (title, abstract, Examples 1 and 2, claim 1).
Antelis teaches the composition includes magnesium in an amount ranging from 100 to 400 mg per serving (paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 4 and 16).
Antelis’ teaching for a beverage composition with hibiscus and magnesium (title, abstract, paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 1, 4, and 16) anticipates instant claim 1.
Antelis’ teaching that the composition includes magnesium in an amount ranging from 100 to 400 mg per serving (paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 4 and 16) anticipates instant claim 3. Prior art that discloses a range with “sufficient specificity” that overlaps the instantly claimed range is anticipatory according to MPEP 2131.03(ii).
In Example 1, Antelis teaches the beverage was bottled so that it could be easily consumed, anticipating instant claim 15, which recites the composition is a liquid ready-to-drink composition.
In Example 1, Antelis teaches that hibiscus and magnesium, among the other ingredients, were mixed together with water to prepare the beverage, anticipating instant claims 17 and 18 which recite combining hibiscus and magnesium, and further combining the mixture with an aqueous liquid.
In Example 3, Antelis teaches that consumption of the hibiscus and magnesium containing beverage resulted in reduced blood pressure among individuals who had high blood pressure (paragraphs 0047 - 0048), anticipating instant claims 19, 22, and 23.
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 non-obviousness.
Claims 1, 3, 5, 11 – 19, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Antelis (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Antelis does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 1, 3, 15, 19, 22, and 23 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Antelis thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
As discussed above, Antelis teaches a beverage composition that includes hibiscus that is effective for lowering blood pressure (title, abstract).
Antelis teaches the composition includes magnesium in an amount ranging from 100 to 400 mg per serving (paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 4 and 16).
Claims 1, 3, 5, 11 – 19, 22, and 23 are rendered prima facie obvious over the teachings of Antelis, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., beverage compositions, hibiscus, magnesium) were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143(i)(a)).
Antelis’ teaching for a beverage composition with hibiscus and magnesium (title, abstract, paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 1, 4, and 16) reads on instant claim 1.
Antelis’ teaching that the composition includes magnesium in an amount ranging from 100 to 400 mg per serving (paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 4 and 16), overlapping on the claimed range of 30 to 420 mg as recited in instant claim 3. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Antelis does not teach that sodium, caffeine, high fructose corn syrup, artificial sweetener, or preservatives are required for the composition, reading on instant claims 5, and 11 – 14.
In Example 1, Antelis teaches the beverage was bottled so that it could be easily consumed, reading on instant claim 15, which recites the composition is a liquid ready-to-drink composition.
Antelis teaches that the composition may be a powdered beverage mix, reading on instant claim 16.
In Example 1, Antelis teaches that hibiscus and magnesium, among the other ingredients, were mixed together with water to prepare the beverage, reading on instant claims 17 and 18.
In Example 3, Antelis teaches that consumption of the hibiscus and magnesium containing beverage resulted in reduced blood pressure among individuals who had high blood pressure (paragraphs 0047 - 0048), reading on instant claims 19, 22, and 23.
Claims 6 – 10, 20, 21, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Antelis (as cited above) further in view of Greenbaum (US 2021/0212983 A1).
Antelis’ teachings are discussed above.
Antelis does not teach the composition contains a cannabinoid or a bioenhancer.
Greenbaum teaches the missing elements of Antelis.
Greenbaum teaches oral compositions containing cannabinoids (abstract, paragraph 0006).
Greenbaum teaches cannabinoids have significant biological effects including pain relief, anti-cancer, and anti-inflammatory effects, among others (paragraph 0006). Greenbaum teaches cannabinoid compositions can be used to treat many diseases, including anxiety disorders, cancers, hypertension, and hypoglycemia, among others (paragraph 0044).
Greenbaum teaches cannabinoids including THC, THCA, CBD, CBDA, CBN, CBC, and CBG, among others (paragraphs 0007 – 0011, Table 1). Greenbaum teaches 1 to 10 mg cannabinoid per dosage unit (paragraphs 0003, 0052, claim 13).
Greenbaum teaches the composition may also include piperine, teaching that piperine is a mouthfeel experience enhancer that produces a tingling feeling (paragraphs 0003, 0021, claim 7).
Greenbaum teaches the composition may include herbal extracts of Allium sativum, Aloe vera, Cuminum cyminum, or Zingiver officinale (paragraph 0014).
Greenbaum teaches the formulation may be an oral solution (paragraph 0038).
The combination of Antelis and Greenbaum’s teachings renders claims 6 – 10, 20, 21, 24, and 25 prima facie obvious as combining prior art elements according to known methods to yield predictable results (MPEP 2143(i)(a)). A person of ordinary skill in the art would be motivated to modify the beverage composition of Antelis to include cannabinoids as taught by Greenbaum because Greenbaum teaches that cannabinoids have significant biological effects and are useful in the treatment of many diseases (paragraphs 0006, 0044). The combination of Antelis and Greenbaum’s teachings would be expected to yield predictable results (i.e. a beverage composition with hibiscus, magnesium, and a cannabinoid) to one of ordinary skill in the art.
The combination of Antelis’ teaching for a beverage composition with hibiscus and magnesium (title, abstract, paragraphs 0005, 0018, 0027 – 0028, Table 1, 0037 – 0038, claims 1, 4, and 16) with Greenbaum’s teaching for an oral composition with cannabinoids (abstract, paragraph 0006) reads on instant claims 6 and 7. A person of ordinary skill in the art would be motivated to modify Antelis’ beverage composition to include cannabinoids because Greenbaum teaches cannabinoids have significant biological effects including pain relief, anti-cancer, and anti-inflammatory effects, among others (paragraph 0006).
Greenbaum’s teaching for 1 to 10 mg cannabinoid per dosage unit (paragraphs 0003, 0052, claim 13), falls within the instantly claimed range of 1 to 20 mg as recited in claim 8. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Greenbaum’s teaching that the composition may include piperine and/or herbal extracts of Allium sativum, Aloe vera, Cuminum cyminum, or Zingiver officinale (paragraphs 0003, 0014, 0021, claim 7) reads on instant claim 9. The instant specification lists piperine, Allium sativum, Aloe vera, Cuminum cyminum, and Zingiver officinale as examples of suitable bioenhancers in paragraph 0079.
Although Greenbaum does not teach a specific amount of piperine or herbal extracts for inclusion in the composition, a person of ordinary skill in the art would be able to arrive at the claimed amounts 1 to 20 mg, as recited in claim 10, via routine experimentation, which is prima facie obvious according to MPEP 2144.05(ii)(a). A person of ordinary skill in the art would be motivated to include these compounds in the same relative amount as the cannabinoids of the composition (paragraphs 0003, 0052, claim 13), because Greenbaum teaches that these compounds are meant to enhance, not overpower, the cannabinoids in the composition. Furthermore, Greenbaum suggests that these compounds are quite strong, therefore a small amount has large effects, and as such a person of ordinary skill in the art would be motivated to experiment with small amounts of these compounds.
The combination of Antelis’ teaching for a beverage composition with hibiscus and magnesium and Greenbaum’s teaching that cannabinoid compositions can be used to treat many diseases, including anxiety disorders, cancers, hypertension, and hypoglycemia, among others (paragraph 0044) reads on instant claims 20, 21, 24, and 25. A person of ordinary skill in the art would have been motivated to include cannabinoids in Antelis’ composition of hibiscus and magnesium because Greenbaum teaches cannabinoid compositions can be used to treat many diseases (paragraph 0044).
Claims 1 – 18, 20, 21, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Sugerman (US 9,040,099 B1).
Sugerman teaches a composition with Hibiscus sabdariffa for treating pain and discomfort of various conditions (title, abstract).
Sugerman teaches the composition can be a beverage, or mixed with drink, foods, or nutritional products (column 11 line 54 to column 12 line 8, column 19 lines 45 – 51).
Sugerman teaches the composition may include minerals essential for human metabolism and health, such as magnesium (column 11 lines 4 – 8, column 12 lines 44 – 45, column 20 lines 6 – 7, lines 28 – 33, claims 8 and 13). Sugerman teaches magnesium stearate as a suitable form of magnesium (column 20 lines 6 – 7, 28 – 33).
Sugerman teaches the composition may include one or more oils from Cannabis sativa, and other botanical ingredients such as quercetin (column 11 lines 2 – 3, column 12 lines 30 – 47).
Claims 1 – 18, 20, 21, 24, and 25 are rendered prima facie obvious over the teachings of Sugerman, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., hibiscus extract, magnesium) were known in the prior art (e.g., health-affecting compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143(i)(a)).
Sugerman’s teaching for a beverage composition with Hibiscus sabdariffa (title, abstract, column 11 line 54 to column 12 line 8, column 19 lines 45 – 51,) reads on instant claims 1 and 2.
Sugerman’s teaching that the composition should include essential minerals such as magnesium (column 11 lines 4 – 8, column 12 lines 44 – 45, column 20 lines 6 – 7, lines 28 – 33, claims 8 and 13) reads on instant claim 3. Sugerman’s teaching that the total plant materials in the composition may be in the amount of 500 mg to 5 g, emphasizing that those skilled in the art will have the necessary expertise to determine appropriate therapeutic amounts (claim 21 lines 65 to column 22 line 41) reads on the claimed range of 30 to 420 mg magnesium recited in claim 3. With Sugerman’s guidance for total plant material in a range of 500 mg to 5 g and the expertise and experience of the art, a person of ordinary skill in the art would be able to arrive at the claimed amounts via routine experimentation, which is prima facie obvious according to MPEP 2144.05(ii)(a).
Sugerman’s teaching for magnesium stearate as a suitable form of magnesium (column 20 lines 6 – 7, 28 – 33) reads on instant claim 4.
Sugerman does not teach that sodium, caffeine, high fructose corn syrup, artificial sweetener, or preservatives are required for the composition, reading on instant claims 5, and 11 – 14.
Sugerman’s teaching that the composition may include one or more oils from Cannabis sativa (column 11 lines 2 – 3, column 12 lines 30 – 47) reads on instant claims 6 and 7. With Sugerman’s guidance for total plant material in a range of 500 mg to 5 g and the expertise and experience of the art, a person of ordinary skill in the art would be able to arrive at the claimed amounts 1 to 20 mg cannabinoid, as recited in claim 8, via routine experimentation, which is prima facie obvious according to MPEP 2144.05(ii)(a).
Sugerman’s teaching that the composition may include quercetin (column 11 lines 2 – 3, column 12 lines 30 – 47) reads on instant claim 9. The instant specification lists quercetin as an example of a suitable bioenhancer in paragraph 0079. As with the relative amounts of magnesium and cannabinoids, Sugerman’s guidance for total plant material in a range of 500 mg to 5 g and the expertise and experience of the art, a person of ordinary skill in the art would be able to arrive at the claimed amounts 1 to 20 mg, as recited in claim 10, via routine experimentation, which is prima facie obvious according to MPEP 2144.05(ii)(a).
Sugerman teaches the composition can be a beverage, or mixed with drink, foods, or nutritional products (column 11 line 54 to column 12 line 8, column 19 lines 45 – 51). Sugerman’s teaching that the composition can be a beverage suggests that the composition is “ready-to-drink”, reading on instant claim 15.
Sugerman teaches the composition can be in the form of dispersible powders or granules (column 20 lines 15 – 19), reading on instant claim 16.
Sugerman teaches the composition is prepared by mixing the botanical ingredients with acceptable excipients such as an aqueous solution or oil medium (column 19 lines 52 – 65, column 20 lines 15 – 19, lines 56 - 64), reading on instant claims 17 and 18.
Sugerman teaches the composition may be useful in treating diseases, conditions, or disorders including heart disease, arthritis, diabetes, cancers, or neurodegenerative diseases (column 21 lines 25 – 39), reading on claims 20 and 24.
Sugerman teaches the phytochemicals in the composition have a range of biological activities in humans including inducing vasodilation and immune response (column 3 lines 61 – 65), reading on claims 21 and 25, which recite “providing immune support”.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612