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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 10/03/25 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-14 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/07/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Please see Page 4 ([0024]) and Page 6 ([0026]) of the instant specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 5 and 14 are objected to because of the following informalities:
In claim 5, line 2, a comma should be added after the term “cannabinoid.”
Claim 14 should be dependent on claim 13 since it is drawn to a nutritional product.
Appropriate correction is required.
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.
Claims 1, 6, and 8 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "… wherein the nutritional product has synergistic effects" in the last two lines. It is unclear which activities or properties are included in the synergistic effects. Clarification and/or amendment are required.
Claim 6 recites “… wherein the at least one additional compound comprises seed hulls of a Cannabis plant …” It is unclear how a compound can comprise seed hulls, which are botanical parts containing many different compounds. Clarification and/or amendment are required.
Claim 8 recites “… wherein the at least one additional compound comprises leaves or roots of a Cannabis plant …” It is unclear how a compound can comprise leaves or roots, which are botanical parts containing many different compounds. Clarification and/or amendment are required.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Werz et al. (PharmaNutrition 2 (2014) 53-60 – “Werz”).
Instant claim 1 is drawn to a method of making a nutritional product comprising:
providing a hemp variety with a zero or near-zero cannabinoid expression;
germinating seeds from the hemp variety to obtain sprouts, wherein the sprouts have elevated levels of a cannflavin, compared to unsprouted hemp seeds or hemp seeds that lack the zero or near-zero cannabinoid phenotype;
adding at least one additional compound derived from Cannabis to the sprouts or product derived from the sprouts; and
making a nutritional product from the sprouts; wherein the nutritional product has synergistic effects.
Werz teaches a cannabinoid-free hemp food product (Title, Abstract). Werz teaches that hemp seeds are of great nutritional value, containing all essential amino acids and fatty acids in sufficient amount and ratio to meet the dietary human demand (Abstract). Werz teaches that along with the nutritional value of hemp seeds, their anti-inflammatory profile of unsaturated fatty acids and pleasant nutty taste, has gained them a “super-food” status in consumers, and that sprouting has been shown to increase the nutritional value of seeds by reducing the concentration of anti-nutritional factors and boosting the production of specific phytochemicals (Page 59, Col. 2, “Layperson’s summary”). Werz teach that Ermo, a variety of hemp devoid of cannabinoids, contains significantly higher amounts of CFA(1) compared to cannabinoids-rich varieties, with minimal contamination from CFB (¶ bridging Pages 58 and 59). Germination of the Ermo variety of hemp seeds was carried out (Page 54, sections 2.2 and 2.3). Sprouting Ermo seeds induced the formation of both CFA(1) and CFB(2) (Page 59, Col. 1, ¶ 1). “Hemp is a prolific producer of structurally unique phenolics (cannflavins, cannabispiranes, canniprenes), present in the leaves and flowers, but absent in the seeds. Since beneficial properties have been associated to these compounds, the induction of their production by sprouting might, in principle, adds value to the product” (Page 54, Col. 1, ¶ 2). The presence of lipophilic flavonoids combines with the high concentration of ω-3 essential acids to qualify sprouts from Ermo as a novel antiinflammatory hemp food product worth considering for mass production and commercial development (Abstract).
Werz does not expressly teach wherein the nutritional product has synergistic effects.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of preparing a cannabinoid-free hemp food product by sprouting seeds from Ermo, which is a variety of hemp devoid of cannabinoids, as taught by Werz, modify the effects of the nutritional product in order to increase and optimize the effect of all of the components while in use together in order to provide the strongest anti-inflammatory properties and nutrition to the subject based on the anti-inflammatory profile of unsaturated fatty acids in hemp, also as taught by Werz, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the recited synergistic effects would have been expected given the anti-inflammatory profile of unsaturated fatty acids in hemp and the anti-inflammatory prenylflavonoids cannflavins A and B (Abstract, ¶ bridging Pages 53 and 54, Page 59, Col. 2, “Layperson’s summary”) and inhibition of prostanoid formation by cannflavins (Page 54, Col. 1, 2nd full ¶), as taught by Werz.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of step a) would have been obvious over the cannabinoid-free hemp food product (Title, Abstract) and Ermo, a variety of hemp devoid of cannabinoids, which contains significantly higher amounts of CFA(1) compared to cannabinoids-rich varieties, with minimal contamination from CFB (¶ bridging Pages 58 and 59), as taught by Werz.
Regarding instant claim 1, the limitation of step b) would have been obvious over the germination of the Ermo variety of hemp seeds (Page 54, sections 2.2 and 2.3) and sprouting Ermo seeds which induced the formation of both CFA(1) and CFB(2) (Page 59, Col. 1, ¶ 1), as taught by Werz.
Regarding instant claim 1, the limitation of step c) would have been obvious over the canniprenes (Page 54, Col. 1, 1st full ¶), as taught by Werz.
Regarding instant claim 1, the limitation of step d) would have been obvious over the cannabinoid-free hemp food product (Title, Abstract, Page 59, Col. 2, “Layperson’s summary”), as taught by Werz. The limitation of synergistic effects would have been expected given the anti-inflammatory profile of unsaturated fatty acids in hemp and the anti-inflammatory prenylflavonoids cannflavins A and B (Abstract, ¶ bridging Pages 53 and 54, Page 59, Col. 2, “Layperson’s summary”) and inhibition of prostanoid formation by cannflavins (Page 54, Col. 1, 2nd full ¶), as taught by Werz.
Regarding instant claim 2, the limitation of the cannflavin which is CFA and/or CFB would have been obvious over the cannflavin A (CVA, 1) and B (CVB, 2) (Page 54, Col. 1, 2nd full ¶), as taught by Werz.
Regarding instant claim 3, the limitation of the zero or near-zero cannabinoid expression comprising expression of less than 0.1% cannabinoids by weight in the mature flower would have been obvious over the Ermo variety of hemp which is devoid of cannabinoids (¶ bridging Pages 58 and 59), as taught by Werz.
Regarding instant claim 4, the limitation of the sprouts comprising at least 0.0002% of cannflavin by weight would have been obvious over the Ermo hemp variety which contains significantly higher amounts of CFA(1) compared to cannabinoids-rich varieties, with minimal contamination from CFB (¶ bridging Pages 58 and 59), as taught by Werz, unless there is evidence of criticality or unexpected results. One of ordinary skill in the art would have found it obvious to modify the amount of cannflavin in the hemp variety taught by Werz based on the desired anti-inflammatory effect.
Regarding instant claims 12-14, the limitations of the product in the form of fresh sprouts or a powder, a nutritional product, a bulk form would have been obvious over the powdered sprouts (Page 55, Col. 1, 2nd ¶) and the cannabinoid-free hemp food product which is worth considering for mass production and commercial development (Title, Abstract) as taught by Werz.
Claims 5-11 are rejected 1 under 35 U.S.C. 103 as being unpatentable over Werz et al. (PharmaNutrition 2 (2014) 53-60 – “Werz”), as applied to claims -4 and 12-14 above, in view of Aung-Din (WO 2018/035212 A1).
Instant claim 5 is drawn to the method of claim 1, wherein the at least one additional compound derived from Cannabis comprises one or more of a non-THC cannabinoid, a terpenoid, and any combination thereof.
The teaching of Werz is discussed above.
Werz does not expressly teach wherein the nutritional product has synergistic effects.
Aung-Din teaches that caryophyllene provides a means of proving medical benefits of cannabinoids without negative aspects of cannabis ([0060]). The term “caryophyllene(s)” includes C15 terpenes including but not limited to beta-caryophyllene ([0064]). Other cannabis terpenoids (e.g., limonene, myrcene, α-pinene, linalool, ß-caryophyllene, caryophyllene oxide, nerolidol and phytol) have been designated Generally Recognized as Safe (GRAS) by the US Food and Drug Administration and other regulatory agencies ([0076]). In certain embodiments, beta-caryophyllene is obtained from hemp ([0067]). Caryophyllene acts on CB2 receptors and this represents potential therapy for inflammation, pain, atherosclerosis, osteoporosis and other conditions ([0070]), wherein CB2 receptors are endocannabinoid receptors found only in peripheral nervous system which appear responsible for anti-inflammatory effect such as pain relief ([0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of preparing a cannabinoid-free hemp food product by sprouting seeds from Ermo, which is a variety of hemp devoid of cannabinoids, as taught by Werz, modify the effects of the nutritional product in order to increase and optimize the effect of all of the components while in use together in order to provide the strongest anti-inflammatory properties and nutrition to the subject based on the anti-inflammatory profile of unsaturated fatty acids in hemp, also as taught by Werz, in view of the use of caryophyllene and terpenoids from Cannabis which are used for anti-inflammatory and pain relief effects, as taught by Aung-Din, and produce the instant invention.
One of ordinary skill in the art would have been motivated to add the caryophyllene and other terpenoids from Cannabis as taught by Aung-Din in the method of Werz in order to augment the anti-inflammatory effect, which is taught by Aung-Din as being not only GRAS but also as therapy for inflammation, pain, atherosclerosis, osteoporosis and other conditions ([0070]).
Regarding instant claim 5, the limitation of a non-THC cannabinoid, a terpenoid, and any combination thereof would have been obvious over the caryophyllene ([0060], [0064], [0067], [0070]) and other cannabis terpenoids like limonene, myrcene, α-pinene, linalool, ß-caryophyllene, caryophyllene oxide, nerolidol and phytol ([0076]), as taught by Aung-Din.
Regarding instant claims 6 and 7, the limitations of the compound derived from seed hulls of a Cannabis plant and cannabisin B would have been obvious over the cannabisin B ([0072]), as taught by Aung-Din.
Regarding instant claims 8 and 9, the limitations of the compound derived from leaves or roots of a Cannabis plant and canniprene would have been obvious over the canniprene (Page 54, Col. 1, 1st full ¶), as taught by Werz, and the canniprene ([0072]), as taught by Aung-Din.
Regarding instant claim 10, the limitation of caryophyllene would have been obvious over the caryophyllene ([0060], [0064], [0067], [0070]), as taught by Aung-Din.
Regarding instant claim 11, the limitation of the synergistic effects comprising either or both of anti-inflammatory activity and anti-oxidant activity would have been obvious over the anti-inflammatory prenylflavonoids cannflavins A and B (Abstract, Page 59, Col. 2, “Layperson’s summary”), as taught by Werz, and by the anti-inflammatory effect of the cannabis terpenoids ([0069], [0070], [0076]), as taught by Aung-Din.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615