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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/27/26 has been entered.
Non Final Rejection
The Status of Claims:
Claims 72-99 is pending.
Claims 72-81 are rejected.
Claims 82-99 are withdrawn from consideration.
DETAILED ACTION
1. Claims 72-81 are under consideration in this Office Action.
Priority
2. It is noted that this application is is a CIP of 17714103 04/05/2022 PAT 11753390 This application is a CIP of 17522866 11/09/2021 PAT 12029718 17714103 is a CON of 17214229 03/26/2021 PAT 11292779 17522866 has PRO of 63106527 10/28/2020.
Drawings
3. The drawings filed on 9/12/2023 are reviewed by the examiner.
IDS
4. The IDS filed on 10/25/23 & 4/1/25 have been reviewed.
The Examiner and applicant’s representative for the telephone interview took place on 11 April 2025. Applicant discussed that the present restriction requirement did not take account of the preliminary amendment filed on 7 April 2025. The Examiner then initiated an oral restriction requirement including the five groups of inventions listed below and requested Applicant to respond in writing:
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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.
6. Claims 72-81 are rejected under 35 U.S.C. 103 as being unpatentable over Tegen et al (US 2020/0255389 A1) in view of Elmes et al (US 2022/0008379 A1), which has a provisional application No. 63/049,310 filed on July. 8, 2020 and MR.HEMPFLOWER ( Delta-8 THC vs. delta-9 THC — what’s the difference between these two hemp cannabinoids?, September 1, 2020 , p.1-9)
Applicant claims the followings:
72. (Previously presented) An industrial hemp derived oil comprising about 73.59% to about 99.73% A-8 tetrahydrocannabinol (THC), wherein the oil has less than 0.3% A-9 THC.
73. (Previously presented) The oil of claim 72, formulated in a food composition having a 0.5- 150 mg dosage of A-8 THC.
74. (Previously presented) The oil of claim 73, wherein the food composition comprises a gummy, a lozenge, a dissolving strip, a candy, a mint, a chewing gum, a chocolate, a brownie, a cookie, a trail bar, a cracker, a mint, a pastry, or a bread.
75. (Previously presented) The oil of claim 74, wherein the food composition is a gummy.
76. (Previously presented) The oil of claim 72, formulated in a gummy having a 0.5-150 mg dosage of A-8 THC.
77. (Previously presented) The oil of claim 72, formulated in a beverage.
78. (Previously presented) The oil of claim 77, wherein the beverage is water, tea, coffee, soda, cider, juice, an energy drink, beer, wine, ale, or liquor.
79. (Previously presented) The oil of claim 72, formulated in an inhalant composition.
80. (Previously presented) The oil of claim 72, formulated in a nutraceutical composition.
81. (Previously presented) The oil of claim 72, formulated in a topical composition
Determination of the scope and content of the prior art
Tegen et al discloses the conversion of CBD to deta-8-THC in the following:
CBD (15 g) was added to 240 ml of reaction solvent and p-toluenesulfonic acid. In this example, the mixture was reacted for 27 hours, although other time periods can also be used, as discussed below. It was then diluted with ether (20 ml) and poured into water. The upper layer was separated, washed with aqueous 5% NaHCO3, then with water, dried over MgSO4 and evaporated. GC-MS analysis on the crude product, showed the presence of 96.5% delta 8-THC and 2.5% delta 9-THC. The crude product was then subjected to column chromatography. In the example described above, normal phase HPLC separation is used wherein the colunm is for example a silica gel and the mobile phase is an organic solvent mixture introduced as a gradient described in the invention. In other embodiments, reverse phase HPLC separation is used (see page 57, a paragraph#0899).
The current invention, however, differs from the prior art in that the oil having less than 0.3% delta-9 THC, the claimed dosage of 0.5-150 mg dosage, and the food composition comprising a gummy, a a pastry, or a bread, and the beverage being is water, tea, coffee, soda, cider, juice, an energy drink, beer, wine, ale, or liquor, an inhalant , nutraceutical, topical composition are unspecified in the prior art
Elmes et al teaches stabilized cannabinoid compositions containing one or more antioxidants in the followings:
The compositions can be provided as a food composition in combination with a food carrier, including but not limited to food bars ( e.g., granola bars, protein bars, candy bars), cereal products (e.g., oatmeal, breakfast cereals, granola), bakery products (e.g., bread, donuts, crackers, bagels, pastries, cakes), dairy products (e.g., milk, yogurt, cheese), beverages (e.g., milk-based beverages, sports drinks, fruit juices, teas, soft drinks, alcoholic beverages, bottled waters), beverage mixes, pastas, grains (e.g., rice, corn, oats, rye, wheat, flour), egg products, snacks ( e.g., candy, chips, gum, gummies, lozenges, mints, chocolate), meats, fruits, vegetables or combinations thereof. Food compositions can comprise solid foods. Food compositions can comprise semi-solid foods. Food compositions can comprise liquid foods as in claim 74,77-78,.(see page 3 , a paragraph#0052)
Compositions for pulmonary administration can be inhaled from any suitable dry powder inhaler device known to a person skilled in the art. In certain instances, the compositions may be conveniently delivered in the form of an aerosol spray from pressurized packs, as in claim 79 (see page 4 , a paragraph#0057).
Typical formulations for topical administration as in claim 81 include creams, ointments, sprays, lotions, hydrocolloid dressings, and patches(see page 5 , a paragraph#0061).
In addition, the composition may further comprise a second agent selected from the group consisting of: cannabinoids,… nutraceutical as in claim 80 (see page 5 , a paragraph#0064).
Furthermore, MR.HEMPFLOWER describes that regarding dosing and consumption, it’s important to remember that the standard dosing for CBD is uniquely designed for the compound and doesn’t translate to other cannabinoids. Because delta-8 is psychotropic, aka causes changes in the perception of sensory information, you need a completely different dosing plan. To get a better sense of it, here’s a simple Delta-8 THC dosage chart for tinctures and other forms of administration:
1. Low tolerance: 5-15 mg per serving
2. Medium tolerance: 15 – 45 mg per serving
3. High tolerance: 45 – 150 mg per serving, as in claims 73 and 76 .
Our delicious Delta-8 THC Gummies quickly took over the market. Each vegan, sugar-free THC gummy as in claims 75-76 offers a distinct flavor and is ideal for stimulating appetite and aiding sleep problems. (see page 9, the second and third paragraphs).
In addition, Delta-8 THC is a lesser-known phytocannabinoid that makes about 0.01 % of the hemp plant. Because this cannabinoid appears in small amounts in hemp, processors extract and concentrate delta-8 into readily-available tinctures, oils, sprays, and edibles. (see page 9, the second and third paragraphs).
Ascertainment of the difference between the prior art and the claims
1. The difference between the instant application and the applied Tegen et al art is that the Tegan et al does not expressly teach the oil having less than 0.3% delta-9 THC, the claimed dosage of 0.5-150 mg dosage, and the food composition comprising a gummy, a a pastry, or a bread, and the beverage being is water, tea, coffee, soda, cider, juice, an energy drink, beer, wine, ale, or liquor, an inhalant , nutraceutical, topical composition. The deficiencies of the Tegan et al are partially cured by Elmes et al and MR.HEMPFLOWER.
The difference between the instant application and the applied Elmes et al et al art is that the Elmes et al does not expressly teach the oil having less than 0.3% delta -9 THC, the claimed purity % and the dosage of delta-8-THC. The deficiencies of the Elmes et al are cured partially by Tegen et al and MR.HEMPFLOWER.
3. The difference between the instant application and the applied MR.HEMPFLOWER art is that the MR.HEMPFLOWER does not expressly teach the oil having less than 0.3% delta -9 THC, the claimed purity % odf delta-8 THC and the food composition comprising a a pastry, or a bread, and the beverage being is water, tea, coffee, soda, cider, juice, an energy drink, beer, wine, ale, or liquor, an inhalant , nutraceutical, topical composition. The deficiencies of the MR.HEMPFLOWER are cured by Tergen et al and Elmes et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claim 72, with respect to the lack of teaching the the oil having less than 0.3% delta -9 THC, Tegen et al does teach that the crude product, showed the presence of 96.5% delta 8-THC and 2.5% delta 9-THC. The crude product was then subjected to column chromatography(see page 57, a paragraph#0899). From these passages, it does suggest that the impurity of delta 9-THC can be further removed for the crude product of delta 8-THC. Therefore, if the skilled artisan in the art had desired to improve the purity of of delta 8-THC, it would have been obvious to be motivated to apply it to column chromatography repeatedly, thereby achieving the oil with less than 0.3% A-9 THC.
Regarding the Claims 73 and 76, with respect to the lack of teaching the claimed dosage of 0.5-150 mg exactly, the MR.HEMPFLOWER prior art does mention generally that a simple Delta-8 THC dosage for tinctures and other forms of administration covers a range of 5-150 mg per serving as a low tolerance (see page 9, the second paragraph). From this information, it is reasonable for the skilled artisan in the art to have assumed that it may be roughly meant as 0.5-150 mg dosage. Therefore, the prior art is relevant ot the claimed invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Tegen expressly discloses the product containing 96.5% delta 8-THC by HPLC Similarly, Elmes et al teaches stabilized cannabinoid compositions containing a gummy, a pastry, or a bread, and the beverage being is water, tea, coffee, soda, cider, juice, an energy drink, beer, wine, ale, or liquor, an inhalant , nutraceutical, topical composition.
Furthermore, MR.HEMPFLOWER does describe a simple Delta-8 THC dosage chart for tinctures and other forms such as gummies of an oral administration.
All three prior art are commonly related to one another with respect to using delta-8 THC composition containing the food and/or beverages composition.
. Moreover, MR.HEMPFLOWER does offer guidance as for the simple dosage tolerance range of Delta-8 THC. (see page 9, the second paragraph)
So, if the skilled artisan in the art had desired to develop a composition containing a pure 86 % of deta-8-THC in the food and/or beverages with the specific dosage range of deta-8-THC, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teaching of MR.HEMPFLOWER ’s Delta-8 THC dosage in combination with the teachings of Elmes et al about food/ or beverage composition into the Tegen’s product. This is because the skilled artisan in the art would expect the combined prior art teachings and products to be successful and feasible as guidance shown in the prior art.
Applicants’ Arguments
Applicants argue in the followings:
Claims 72-81 are rejected under 35 U.S.C. §103 are allegedly unpatentable over Webster et al. (US 2008/0221339 Al) in view of Elmes et al (US 2022/0008379 Al) and Mr. Hempflower (Delta-8 THC vs. delta-9 THC what's the difference between these two hemp cannabinoids?, September 1, 2020 , p.1-9). Applicant respectfully traverses this rejection.
Independent claim 72 recites: An industrial hemp derived oil comprising about 73.59% to about 99.73% A-8 tetrahydrocannabinol (THC), wherein the oil has less than 0.3% A-9 THC.
Applicant maintains that the alleged combination of Webster, Elmes, and Mr.
Hempflower does not teach or suggest:
i. a A-8 THC oil derived from industrial hemp ("industrial hemp" limitation);
ii. an industrial hemp derived oil comprising about 73.59% to about 99.73% A-
8 THC ("high purity" limitation), or
iii. an industrial hemp derived oil comprising about 73.59% to about 99.73%
A-8 THC and less than 0.3% A-9 THC ("A-9 THC" limitation).
First, regarding the industrial hemp limitation, Applicant previously argued that Webster uses synthetic CBD as starting material and not industrial hemp, therefore Webster does not teach or suggest an industrial hemp derived oil, nor an industrial hemp derived oil having the high purity limitation and the A-9 THC limitation. However, the Examiner states that Webster doesn't specify the starting material of their CBD, and uses the passage in paragraph [0004] to bridge the gap and argue that "there is a high chance or motivation that Webster could have used the natural industrial hemp having varieties of the Cannabis plant containing CBD that have a low content of delta-9 THC for the purpose of production of a pure delta-8 THC oil instead of using the synthetic CBD
as the starting material." (emphasis added). In other words, the Examiner's obviousness rationale is based on paragraph [0004] and that Webster could have used industrial hemp, although it is not specified.
At the outset, Webster's disclosure in paragraph [0004] is in the background section. This is the only reference to industrial hemp in Webster and, when taken in context, is simply background material discussing the difference between marijuana and industrial hemp. Importantly, Webster is silent about isolating CBD from any source, including industrial hemp. Indeed, Webster teaches nothing about how to isolate CBD from any source. Webster simply teaches conversion of CBD to A-8 THC and also to A-9 THC - and nothing else. Moreover, could have is not the legal standard for obviousness. It is whether one would have made the claimed product from the cited art. Because Webster is silent on any CBD isolation techniques and starting materials, Applicant submits that Webster provides no suggestion or motivation to use industrial hemp as a starting material to make a highly pure A-8 THC oil - nor a reasonable expectation of success. For these reasons alone, claims 72-81 are not prima facie obvious over the cited art.
However, to further support Applicant's position, Webster was filed in March 2001. Applicant submits an Expert Declaration herein to support that industrial hemp was not being used as a starting material prior to 2018. This is because industrial hemp was a controlled substance prior to the 2018 Farm Bill which removed hemp derived cannabinoids as a controlled substance from the Controlled Substances Act. It is this removal which triggered a revolution in industrial hemp genetics to breed industrial hemp varieties. Thus, industrial hemp was not being used as a starting material prior to 2018.
Second, regarding the A-9 THC limitation the Examiner argues that the limitation of "less than 0.3% delta-9 THC" reads on zero, therefore Webster does teach this limitation. "Less than 0.3%" does read on zero, or in other words, the absence of A-9 THC in the oil. However, in Example 1 Webster is converting 300 mg CBD to A-8 THC. Webster does not teach the 300 mg
CBD is derived from industrial hemp, and thus it follows that Webster does not teach one skilled in the art how to make an oil derived from industrial hemp having the high % of A-8 THC and low amount of A-9 THC as claimed. For at least this further reason, claims 72-81 are not prima facie obvious over the cited art.
Applicant respectfully requests withdrawal of the present rejection.
Regarding applicant’s arguments, the examiner considered them.
However, as indicated in the above, finding a new prior art, another 103 rejection seems necessary. Therefore, applicant’s arguments are not persuasive at this time.
Conclusion
Claims 72-81 are rejected.
Claims 82-99 are withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 2/7/2026