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`Sent: 8/29/2022 9:30:13 AM
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`To: TTAB EFiling
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`CC:
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`Subject: U.S. Trademark Application Serial No. 88979768 - UNCLE BUD'S INDUSTRIAL HEMP -
`116242.00015 - EXAMINER BRIEF
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`*************************************************
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`Attachment Information:
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`Count: 3
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`Files: 2022-08-15_8-54-07.jpg, 2022-08-15_8-54-13.jpg, 88979768.doc
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`United States Patent and Trademark Office (USPTO)
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`U.S. Application Serial No. 88979768
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`Mark: UNCLE BUD'S INDUSTRIAL HEMP
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`Correspondence Address:
` Daniel H. Bliss
` HOWARD & HOWARD ATTORNEYS PLLC
` 450 WEST FOURTH STREET
` ROYAL OAK, MI 48067
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`Applicant: CBH International, LLC
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`Reference/Docket No. 116242.00015
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`Correspondence Email Address:
` ipdocket@h2law.com
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`EXAMINING ATTORNEY’S APPEAL BRIEF
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` Applicant has appealed the trademark examining attorney's1 refusal to register the
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`mark UNCLE BUD'S INDUSTRIAL HEMP NATURE'S ORIGINAL MADE WITH
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`CANTATREX + A TRUSTED FAMILY FORMULA (design plus words) for the goods “topical
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`analgesics; analgesic balms; all of the foregoing containing ingredients naturally occurring in
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`industrial hemp with a delta-9 tetrahyrocannabinol (THC) concentration of not more than 0.3% on
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`a dry weight basis” in Class 5, pursuant to Trademark Act Sections 1 and 45, 15 U.S.C. §§1051,
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`1127, on the ground that applicant does not have a bona fide intent to lawfully use the mark in
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`commerce.
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`FACTS
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`On July 1, 2019, applicant, CBH International, LLC, filed an intent to use application
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`pursuant to Section 1(b) of the Trademark Act for the mark UNCLE BUD'S INDUSTRIAL HEMP
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`NATURE'S ORIGINAL MADE WITH CANTATREX + A TRUSTED FAMILY FORMULA
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`(design plus words) (hereinafter “UNCLE BUD’S”) for the goods “cosmetics and cleaning
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`1 This application was originally assigned to examining attorney Eric Sable, was reassigned to examining attorney
`Leslee Friedman on April 26, 2021, and then to the undersigned examining attorney on August 5, 2022.
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`
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`preparations; skincare; skincare products; cosmetic products; tropical pain relief” in Class 3 and
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`“pharmaceuticals; hemp powder; hemp capsules; topical analgesics; analgesic balm; topical gel for
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`medical and therapeutic treatment of minor aches and pains of muscles and joint” in Class 5.
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`On June 18, 2020, the examining attorney refused registration pursuant to Sections 1 and 45
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`of the Trademark Act due to the applicant not having a bona fide intent to lawfully use the mark in
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`commerce due to the goods not being lawful under the Food, Drug and Cosmetic Act (FDCA).
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`The examining attorney also partially refused registration pursuant to Section 2(d) of the
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`Trademark Act for the goods in Class 3; required a Disclaimer of the wording “INDUSTRIAL
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`HEMP”, “ORIGINAL” and “FAMILY FORMULA”; required amendments to the Identification of
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`Goods; and required amendments to the Mark Description.
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`On October 2, 2020, applicant filed a Request to Divide, maintaining only the goods in
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`Class 5 in the instant application. On December 10, 2020 applicant filed a Response in which
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`applicant provided arguments against the Sections 1 and 45 refusal based on the FDCA. Applicant
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`also amended the Identification of Goods, provided a Disclaimer, and amended the Mark
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`Description. On April 30, 2021, the examining attorney issued an Office Action in which the
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`Sections 1 and 45 Refusal based on the Food, Drug, and Cosmetic Act was maintained and
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`continued. The examining attorney informed applicant that the Section 2(d) Refusal was obviated
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`and requirements to amend the Identification of Goods, provide a Disclaimer, and amend the Mark
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`Description were all satisfied.
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`On October 19, 2021, applicant filed a Response in which applicant provided additional
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`arguments against the Sections 1 and 45 Lawful Use in Commerce Refusal based on the FDCA.
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`On October 28, 2021, the examining attorney issued a Final Refusal based on the Sections 1 and 45
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`Refusal.
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`On April 28, 2022, applicant filed a Request for Reconsideration in which applicant made
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`further arguments regarding the Sections 1 and 45 Lawful Use Refusal, in conjunction with filing
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`applicant’s Notice of Appeal. The examining attorney denied reconsideration on May 23, 2022.
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`On July 20, 2022, applicant filed its brief, which was forwarded to the examining attorney
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`for statement on the same day.
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`
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`ISSUE
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`The sole issue on appeal is whether the applicant had a bona fide intent to lawfully use its
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`mark in commerce on the goods in Class 5, pursuant to Sections 1 and 45 of the Trademark Act,
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`based on prohibitions in the Federal Food, Drug, and Cosmetic Act (FDCA).
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`ARGUMENT
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`
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`APPLICANT DOES NOT HAVE A BONA FIDE INTENT TO LAWFULLY
`USE THE MARK IN COMMERCE BECAUSE THE GOODS TO WHICH
`THE MARK WILL BE APPLIED ARE UNLAWFUL UNDER THE FOOD,
`DRUG AND COSMETIC ACT
`
`Applicant does not have a bona fide intent to lawfully use its mark, UNCLE BUD’S, in
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`commerce for the goods “topical analgesics; analgesic balms; all of the foregoing containing
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`ingredients naturally occurring in industrial hemp with a delta-9 tetrahyrocannabinol (THC)
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`concentration of not more than 0.3% on a dry weight basis” in Class 5. Trademark Act Sections 1
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`and 45, 15 U.S.C. §§1051, 1127; see TMEP §907. Applicant’s goods are a per se violation of the
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`Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321(g)(1) because applicant’s analgesic goods
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`are for the cure, mitigation, treatment or prevention of disease and/or are intended to affect the
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`structure of or any function of the body and contain CBD.
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`To qualify for federal trademark registration, the use of a mark in commerce must be
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`lawful. Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir.
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`1987) (stating that “[a] valid application cannot be filed at all for registration of a mark without
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`
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`‘lawful use in commerce’”); TMEP §907; see In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB
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`1968); Coahoma Chemical Co., Inc. v. Smith, 113 USPQ 413 (Com’r Pat. & Trademarks 1957)
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`(concluding that “use of a mark in connection with unlawful shipments in interstate commerce is
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`not use of a mark in commerce which the [Office] may recognize.”). Thus, the goods to which the
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`mark is applied must comply with all applicable federal laws. See In re Brown, 119 USPQ2d 1350,
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`1351 (TTAB 2016) (citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB
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`1993) (noting that “[i]t is settled that the Trademark Act’s requirement of ‘use in commerce,’
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`means a ‘lawful use in commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB
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`1976); TMEP §907.
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`Here, the goods to which the proposed mark are intended to be applied are unlawful under
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`the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321(g)(1) because applicant’s goods
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`include items that are intended for use in the cure, mitigation, treatment or prevention of disease
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`and/or are intended to affect the structure of or any function of the body. Specifically, applicant’s
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`identification specifies analgesics,2 goods for relieving pain, and indicates that the goods “contain[]
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`ingredients naturally occurring in industrial hemp with a delta-9 tetrahyrocannabinol (THC)
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`concentration of not more than 0.3% on a dry weight basis”. CBD is derived from and is naturally
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`occurring in hemp. See evidence from Healthline.com, attached to June 18, 2020 Office Action,
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`page 82 in TSDR; evidence from Medicalnewstoday.com, id., page 92 in TSDR (stating CBD is
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`2 See attached definition from MerriamWebster.com, defining “analgesic” as “an agent producing diminished sensation
`to pain without loss of consciousness : a drug that is used to relieve pain and produce analgesia”. https://www.merriam-
`webster.com/dictionary/analgesic. The Trademark Trial and Appeal Board may take judicial notice of dictionary
`definitions that (1) are available in a printed format, (2) are the electronic equivalent of a print reference work, or (3)
`have regular fixed editions. See In re Inn at St. John’s, LLC, 126 USPQ2d 1742, 1747 n.15 (TTAB 2018) (taking
`judicial notice of definition from Dictionary.com because it was from The Random House Unabridged Dictionary),
`aff’d per curiam, 777 F. App’x 516, 2019 BL 343921 (Fed. Cir. 2019); In re Jimmy Moore LLC, 119 USPQ2d 1764,
`1768 (TTAB 2016) (taking judicial notice of definitions from Merriam-Webster Online Dictionary at www.merriam-
`webster.com); In re Red Bull GmbH, 78 USPQ2d 1375, 1378 (TTAB 2006) (taking judicial notice of definition from
`Encarta Dictionary because it was readily available in specifically denoted editions via the Internet and CD-ROM);
`TBMP §1208.04; TMEP §710.01(c); see also Fed. R. Evid. 201; 37 C.F.R. §2.122(a).
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`
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`derived from the stalks and flowers of the hemp plant). Applicant’s website includes CBD topical
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`goods for sale. See evidence from UncleBudsHemp.com, attached to June 18, 2020 Office Action,
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`pages 74-75 in TSDR. Applicant also states in its brief “the current Applicant’s goods contain
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`CBD derived from industrial hemp”. See Applicant’s Appeal Brief at 5.
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`However, such goods cannot legally contain CBD without approval from the Food and
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`Drug Administration. Cannabidiol (CBD) is a chemical constituent of the cannabis plant. On June
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`25, 2018, the U.S. Food and Drug Administration (FDA) approved the first prescription
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`pharmaceutical formulation of plant-derived CBD, Epidiolex®, for the treatment of two rare forms
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`of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The Drug Enforcement
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`Administration (DEA) placed Epidiolex® on schedule V of the CSA on September 27, 2018. No
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`other cannabis-derived drug products have been approved by the FDA. Under the FDCA, any
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`product intended to have a therapeutic or medical use, and any product (other than a food) that is
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`intended to affect the structure or function of the body of humans or animals, is a drug. 21 U.S.C.
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`§ 321(g)(1). An unapproved new drug cannot be distributed or sold in interstate commerce unless
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`it is the subject of an FDA-approved new drug application (NDA) or abbreviated new drug
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`application (ANDA). 21 U.S.C. §§ 331(d) and 355(a), (b), & (j); see also FDA Regulation of
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`Cannabis and Cannabis-Derived Products: Questions and Answers, copy attached to June 18, 2020
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`Office Action, page 72 in TSDR; Statement from FDA Commissioner Scott Gottlieb, MD on the
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`signing of the Agricultural Improvement Act, copy attached to June 18, 2020 Office Action, page
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`73 in TSDR.
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`New drugs may not be legally introduced or delivered for introduction into interstate
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`commerce without prior approval from the FDA, as described in 21 U.S.C. §§331(d) and 355(a).
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`In order for an application to have a valid basis that could properly result in a registration, the use
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`of the mark has to be lawful. See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976).
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`
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`The claimed use of the mark in commerce without FDA approval would be unlawful use in
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`commerce.
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`Here, applicant’s goods are topical analgesics. These goods consequently “affect the
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`structure or body of humans”, as they relieve pain. The FDA has specifically warned companies
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`that pain-relieving products containing CBD, naturally occurring or otherwise, are not legal under
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`the FDCA. See evidence from FDA.com FDA News Release (“FDA Warns Companies Illegally
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`Selling Over-the-Counter CBD Products for Pain Relief”), attached to October 28, 2021 Office
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`Action, pages 2-4 in TSDR; CannabisLegalHighlights.com (“CBD Regulation: Recent FDA
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`Enforcement Casts a Wide Net over CBD Products”), id., pages 5-8 in TSDR);
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`EveryCRSReport.com (“FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview
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`and Considerations for Congress”), id., page 9 in TSDR). Therefore, these goods are not legal
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`under the FDCA.
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`In order for an application to have a valid basis that could properly result in a registration,
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`the use of the mark has to be lawful. See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB
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`1976). Because use of the applied-for mark in connection with such goods was not lawful as of the
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`filing date, applicant did not have a bona fide intent to lawfully use the applied-for mark in
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`commerce in connection with such goods. See In re JJ206, LLC, 120 USPQ2d 1568, 1569 (TTAB
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`2016) (“where the identified goods are illegal under the federal Controlled Substances Act (CSA),
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`the applicant cannot use its mark in lawful commerce, and ‘it is a legal impossibility’ for the
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`applicant to have the requisite bona fide intent to use the mark.”); see also In re Brown, 119
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`USPQ2d, 1351-1352; TMEP §907.
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`Therefore, applicant does not have a bona fide intent to lawfully use the goods in
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`commerce, as such goods are unlawful under the Food, Drug and Cosmetic Act. Thus, registration
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`is refused pursuant to Sections 1 and 45 of the Trademark Act.
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`
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`Applicant’s Arguments Regarding Unlawful Use Refusal
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`Applicant provides several arguments against this refusal. However, for the reasons set
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`forth below, these are not persuasive.
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`First, applicant argues that it is the owner of U.S. Registration No. 5305026 which also
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`contains analgesic goods that contain CBD. This is not persuasive. It is well settled that each
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`application must be decided on its own facts; the USPTO is not bound by prior decisions involving
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`different records. See In re Boulevard Ent., Inc., 334 F.3d 1336, 1343, 67 USPQ2d 1475, 1480
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`(Fed. Cir. 2003) (citing In re Nett Designs, Inc., 236 F.3d at 1342, 57 USPQ2d at 1566); In re
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`Datapipe, Inc., 111 USPQ2d 1330, 1336 (TTAB 2014); TMEP §1209.03(a). The examining
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`attorney notes that U.S. Registration No. 5305026 was registered in 2017, before the amendments
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`in the 2018 Farm Bill and subsequent clarification from the FDA regarding cannabidiol.
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`Therefore, this prior registration is not sufficient to show that applicant has an intent to lawfully
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`use the mark in commerce.
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`Moreover, the Trademark Trial and Appeal Board has previously determined that applicants
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`do not have a bona fide intent to use marks lawfully in commerce when CBD has been added to
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`medicated products without prior approval from the FDA. Specifically, in In re AgrotecHemp
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`Corp., the Board affirmed an unlawful use refusal under Sections 1 and 45 of the Trademark Act
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`based on the FDCA wherein applicant filed an intent to use application for use with pharmaceutical
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`plant extracts containing CBD. In re Agrotechemp Corp., Serial No. 88979905, 2022 TTAB
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`LEXIS 65 (Trademark Trial & App. Bd. February 10, 2022). Specifically, the Board noted that
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`“[t]he FDA requires any product marketed with a claim of therapeutic benefit and containing
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`cannabis or cannabis-derived compounds (such as CBD) to be approved for its intended use before
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`it may be introduced into interstate commerce. Because Applicant [in that case had] not made of
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`record an NDA or ANDA for its goods, it was unlawful for Applicant to introduce such goods into
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`
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`interstate commerce as of the application filing date.” Id. at *4; see also In re Harbor Hemp
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`Company LLC, Serial Nos. 88377702 and 88377730, 2022 TTAB LEXIS 55 (Trademark Trial &
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`App. Bd. January 27, 2022) (affirming an unlawful use refusal under Sections 1 and 45 of the
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`Trademark Act based on the FDCA for Class 005 medicated products and supplements containing
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`CBD).
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`The same is true in this case – applicant has not provided any evidence that it has sought
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`FDA approval, and in fact, affirmatively asserts that its goods are not drugs or subject to FDA
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`approval. See Applicant’s December 10, 2020 response, TSDR page 5. Moreover, applicant also
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`attempts to claim that its products are not therapeutic in nature, but at the same token, identifies
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`products in Class 5 that are described as topical analgesics and analgesic balms. These arguments
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`are not persuasive, because as discussed earlier, analgesics are defined as drugs used for relieving
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`pain, and as such, it is clear by definition that the identified goods are drugs designed to affect the
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`structure of the body. See attached definition from Merriam-Webster. Therefore, because new
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`drugs cannot be entered into interstate commerce without prior approval from the FDA, applicant
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`did not have a bona fide intent to enter its products into lawful commerce.
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`Second, applicant argues that its goods are not subject to the FDCA because its goods are
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`topical analgesics and balms and are not to be ingested. This is not persuasive. The FDA has
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`specifically issued warnings to manufacturers of topical CBD products when such products make
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`therapeutic or medical claims, or are for the treatment of conditions. See evidence from
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`CannabisLegalHighlights.com, attached to October 28, 2021 Office Action, pages 5-8 in TSDR
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`(“In other words, a drug manufacturer cannot add CBD to a non-prescription over-the-counter
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`(OTC) pain cream, even if CBD is listed as in[sic] ‘inactive ingredient’.”); evidence from
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`EverCRSReport.com, id., page 9 in TSDR (“if a CBD-containing cosmetic product makes
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`
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`therapeutic claims… FDA would likely consider the product to be a drug subject to the new drug
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`requirements.”). Thus, the evidence demonstrates that such goods are prohibited under the FDCA.
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`Third, applicant argues that the goods lawful under the Food, Drug and Cosmetic Act
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`because the goods contain naturally occurring CBD. While applicant’s CBD may be legal under
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`the Controlled Substances Act, this does not mean the goods are legal under the Food, Drug, and
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`Cosmetic Act. The FDCA does not make any exception for CBD that is naturally occurring. See In
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`re Harbor Hemp Co., 2022 TTAB LEXIS 55, at *10 (“The fact that Applicant’s goods may be
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`derived from “legally produced industrial hemp extract” does not obviate their unlawfulness under
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`the FDCA. The FDA requires any product marketed with a claim of therapeutic benefit and
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`containing cannabis or cannabis-derived compounds (such as hemp) to be approved for its
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`intended use before it may be introduced into interstate commerce whether hemp-derived or
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`not.”); see also Statement from FDA Commissioner Scott Gottlieb, M.D. on the signing of the
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`Agriculture Improvement Act (discussing that CBD products are regulated by the FDA “This is
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`true regardless of the source of the substance, including whether the substance is derived from a
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`plant that is classified as hemp under the Agriculture Improvement Act”), attached to June 18,
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`2020 Office Action, page 73 in TSDR. Therefore, contrary to applicant’s assertions, the FDA
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`draws no distinction as to the source of the CBD and CBD that may be legal under the Agriculture
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`Improvement Act is not necessarily a legal ingredient of goods under the Food, Drug, and
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`Cosmetic Act. As discussed above, the FDA has also specifically taken action against topical pain
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`goods that contain CBD. See evidence from FDA.com FDA News Release (“FDA Warns
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`Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief”), attached to October
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`28, 2021 Office Action, pages 2-4 in TSDR; CannabisLegalHighlights.com (“CBD Regulation:
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`Recent FDA Enforcement Casts a Wide Net over CBD Products”), id., pages 5-8 in TSDR);
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`EveryCRSReport.com (“FDA Regulation of Cannabidiol (CBD) Consumer Products: Overview
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`
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`and Considerations for Congress”), id., page 9 in TSDR). Thus, applicant’s goods are unlawful
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`pursuant to the Food, Drug and Cosmetic Act.
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`For the reasons set forth above, applicant’s arguments do not overcome this refusal.
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`
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`CONCLUSION
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`Therefore, because the goods to which the mark is intended to be applied are not lawful
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`under the Food, Drug and Cosmetic Act, applicant does not have a bona fide intent lawfully to use
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`the mark under Sections 1 and 45 of the Trademark Act. The examining attorney respectfully
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`requests that the Board affirm the refusal to register the mark pursuant to Trademark Act Sections 1
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`and 45, 15 U.S.C. §§1051, 1127.
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`
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`Respectfully submitted,
`
`/Alison Keeley/
`Examining Attorney
`Law Office 113
`(571) 272-4514
`Alison.Keeley@uspto.gov
`
`
`
`Myriah Habeeb
`Managing Attorney
`Law Office 113
`571-272-8909
`Myriah-Habeeb@uspto.gov
`
`
`
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`
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`Merriam-
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`Webster
`analgesic
`x Q
`SINGSEMIE
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`BUCrey
`ttstiela's
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`Phi.
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`aN COLE AY)
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`ONISLAND TIME
`\ a-nal-'jé-zik@®,-sik \
`
`analgesic noun
`
`
`analgesic |
`
`Definition of analgesic (Entry 1 of 2)
`: an agent producing diminished sensation to pain without loss of consciousness:
`a drugthat is used to relieve pain and produce analgesia
`// opioid analgesics
`// a topical analgesic
`// Aspirin and acetaminophenarethe oral analgesics of first choice in the treatment
`of mild to moderate pain caused by cancer.
`— William T. McGivneyetal.
`
`Midyear Outlook 2022
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`Ad by Merill
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`WORD OF THE DAY
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`dilatory®
`https://www.merriam-webster.com/dictionary/analgesic
`8:53:56 AM 8/15/2022
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`SINCE1828
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`analgesic
`Dictionary
`
`analgesic adjective
`Definition of analgesic (Entry 2 of 2)
`: relating to, characterized by, or producing analgesia : relieving or lessening pain
`without loss of consciousness
`// Ginger, a memberof the same plant family as turmeric, contains anti-
`inflammatory compoundsandvolatile oils ... that show analgesic and sedative
`effects in animal studies.
`— Anahad O'Connor
`// analgesic drugs
`// a topical analgesic cream
`also : caused by the use of analgesics
`
`WORD OF THE DAY
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