United States Patent and Trademark Office (USPTO)
Office Action (Official Letter) About Applicant’s Trademark Application
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U.S. Application Serial No. 90045408
Mark: VITALITY
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Correspondence Address: 61489, BURNT VALLEY ROAD, ANZA
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Applicant: Whitaker Steven
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Reference/Docket No. N/A
Correspondence Email Address: |
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NONFINAL OFFICE ACTION
The USPTO must receive applicant’s response to this letter within six months of the issue date below or the application will be abandoned. Respond using the Trademark Electronic Application System (TEAS). A link to the appropriate TEAS response form appears at the end of this Office action.
Issue date: November 11, 2020
The referenced application has been reviewed by the assigned trademark examining attorney. Applicant must respond timely and completely to the issue(s) below. 15 U.S.C. §1062(b); 37 C.F.R. §§2.62(a), 2.65(a); TMEP §§711, 718.03.
A. Prior Pending Application: Not Entitled to Register
The Office records have been searched and no similar registered mark has been found that would bar registration under Trademark Act Section 2(d), 15 U.S.C. §1052(d). TMEP §704.02. However, please be advised that potentially conflicting marks in prior-filed pending applications may present a bar to registration. The filing dates of pending U.S. Application Serial Nos. 88426486,88604321, 88604326, 88646413, 88605832, 88750150, 88788029, 88844540, 88849441, 88943807, 88977368 and 90042288 precede applicant’s filing date. See attached referenced applications. If one or more of the marks in the referenced applications register, applicant’s mark may be refused registration under Trademark Act Section 2(d) because of a likelihood of confusion with the registered mark(s). See 15 U.S.C. §1052(d); 37 C.F.R. §2.83; TMEP §§1208 et seq. Therefore, upon receipt of applicant’s response to this Office action, action on this application may be suspended pending final disposition of the earlier-filed referenced applications.
In response to this Office action, applicant may present arguments in support of registration by addressing the issue of the potential conflict between applicant’s mark and the marks in the referenced applications. Applicant’s election not to submit arguments at this time in no way limits applicant’s right to address this issue later if a refusal under Section 2(d) issues.
B. CONTROLLED SUBSTANCES ACT REFUSAL & RESPONSE OPTIONS AVAILABLE TO APPLICANT TO OVERCOME REFUSAL
Use of a mark in commerce must be lawful use to be the basis for federal registration of the mark. Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987) (stating that “[a] valid application cannot be filed at all for registration of a mark without ‘lawful use in commerce’”); TMEP §907. Thus, the goods and/or services to which the mark is applied must comply with all applicable federal laws. See In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016) (citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) (noting that “[i]t is settled that the Trademark Act’s requirement of ‘use in commerce,’ means a ‘lawful use in commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976); TMEP §907.
The application identifies a connection to cannabidiol (CBD). CBD is a nonpsychoactive constituent of the cannabis plant. Goods containing CBD derived from cannabis that meets the definition of “marijuana” are illegal under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971. In addition, on December 20, 2018, the CSA was amended to remove “hemp” from the definition of “marijuana” and specifically exclude “tetrahydrocannabinols in hemp (as defined under section 297A of the Agricultural Marketing Act of 1946)” from Schedule I, 21 U.S.C. §812(c)(17). See the Agriculture Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill), which amends the Agricultural Marketing Act of 1946 (AMA). Thus, certain goods and/or services containing or involving hemp, CBD derived from hemp, and/or CBD with less than .3% THC that were used in commerce or intend to be used in commerce on or after December 20, 2018 may be lawful under the CSA.
However, applicant should note that even hemp-derived CBD products may be subject to an additional unlawful use refusal under the Food, Drug and Cosmetic Act as addressed below.
The application is currently refused under the CSA because applicant’s Identification of Goods and/or Services does not identify the source of and/or the THC content of the applicant’s CBD.
Thus, the application includes items or activities that are prohibited under the CSA, and as such applicant currently does not have a valid filing basis for any such items or activities.
To the extent applicant’s goods or services involving goods are derived solely from cannabis plants that meet the current statutory definition of “hemp,” and were used or will be used on or after December 20, 2018, such goods and/or services may be lawful if applicant adopts the following response options addressed below.
In addition, Applicant must also amend the identification of goods and/or services to specify that the cannabidiol-containing items offered are “solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.”
Applicant may adopt one of the following limitations and amend the identification of goods and/or services accordingly:
Plant extracts for medical, veterinary and pharmaceutical purposes any CBD in the goods being solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis”
Applicant is advised that additional amendments to the Identification of Goods and Services are required for clarification purposes as addressed below in this Office Action. The above proposals are required and presented in order to satisfy only the CSA refusal.
SCOPE ADVISORY: Applicant may amend the identification to clarify or limit the goods and/or services, but not to broaden or expand the goods and/or services beyond those in the original application or as acceptably amended. See 37 C.F.R. §2.71(a); TMEP §1402.06. Generally, any deleted goods and/or services may not later be reinserted. See TMEP §1402.07(e).
If applicant adopts the following above response option, the CSA refusal will be withdrawn. However, applicant should note that this response option does not obviate the additional unlawful use refusal under the Food, Drug and Cosmetic Act as addressed below.
C. Section 1 and 45 refusal - Based on ID – Not Lawful Use in Commerce
Registration is refused because the applied-for mark is not in lawful use in commerce. Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see TMEP §907. The goods/services to which the mark is applied must comply with all applicable federal laws. See In re Brown, 119 USPQ2d 1350, 1351 (TTAB 2016) (citing In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993) (noting that “[i]t is settled that the Trademark Act’s requirement of ‘use in commerce,’ means a ‘lawful use in commerce’”)); In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976); TMEP §907.
This refusal issues when “(1) a violation of federal law is indicated by the application record or other evidence, such as when a court or a federal agency responsible for overseeing activity in which the applicant is involved, and which activity is relevant to its application, has issued a finding of noncompliance under the relevant statute or regulation, or (2) when the applicant’s application-relevant activities involve a per se violation of a federal law.” In re Brown, 119 USPQ2d at 1351 (citing Kellogg Co. v. New Generation Foods Inc., 6 USPQ2d 2045, 2047 (TTAB 1988); Santinine Societa v. P.A.B. Produits, 209 USPQ 958, 964 (TTAB 1981)); TMEP §907.
The items or activities listed in the application for which use of the mark is alleged involve a per se violation of federal law. See In re Brown, 119 USPQ2d at 1352. The Federal Food, Drug, and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of a food to which has been added a drug approved under Section 355 of the Act or a biological product licensed under 42 U.S.C. §262. 21 U.S.C. §331(ll); see also 21 U.S.C. §321(ff) (indicating that a dietary supplement is deemed to be a food within the meaning of the FDCA and does not include an article that is approved as a new drug under 21 U.S.C. §355, certified as an antibiotic under 21 U.S.C. §357, or licensed as a biologic under 42 U.S.C. §262).
Cannabidiol (CBD), a chemical constituent of the cannabis plant, was the subject of substantial clinical investigations before it was marketed in foods or as dietary supplements. On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved the first prescription pharmaceutical formulation of plant-derived CBD, Epidiolex®, for the treatment of two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The Drug Enforcement Administration (DEA) placed Epidiolex® on schedule V of the CSA on September 27, 2018. Nevertheless, marijuana and CBD derived from marijuana remain unlawful. No other cannabis-derived drug products have been approved by the FDA. Under the FDCA, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. 21 U.S.C. § 321(g)(1) An unapproved new drug cannot be distributed or sold in interstate commerce unless it is the subject of an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA). 21 U.S.C. §§ 331(d) and 355(a), (b), & (j); see also FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers http://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers copy attached.
In the present case, the application identifies applicant’s goods and/or services as follows: Plant extracts for medical, veterinary and pharmaceutical purposes and the specimen shows use of CBD.
It is unlawful to introduce food to which CBD, an “article that is approved as a new drug,” has been added into interstate commerce or to market CBD as, or in, dietary supplements, regardless of whether the substances are hemp-derived. 21 U.S.C. §§321(ff)(3)(B)(ii), 331(d), 355(a); see also 21 U.S.C. §352(f)(1) regarding mislabeled drugs. See also Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compoundshttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm copy attached. Therefore, the applicant’s limitation statement indicating that the CBD included in the applicant’s goods is 2018 Farm Bill Compliant, or derived from hemp containing less than .3% tetrahyrocannabinol (THC) does not obviate this refusal.
Furthermore, products containing CBD identified for use by animals are unapproved new animal drugs that are deemed unsafe under 21 U.S.C. §360b(a). Under 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of §348 is adulterated within the meaning of Section 342(a)(2)(C)(i) of the FDCA. Introduction of an adulterated animal food into interstate commerce is prohibited under Section 331(a) of the FDCA, 21 U.S.C. 331(a). >
In order for an application to have a valid basis that could properly result in a registration, the use of the mark has to be lawful. See In re Pepcom Indus., Inc., 192 USPQ 400, 401 (TTAB 1976) Accordingly, because applicant’s goods and/or services consist of or include items or activities that are a per se violation of federal law, the applied-for mark as used in connection with such goods and/or services is not in lawful use in commerce.
How to respond. Click to file a response to this nonfinal Office action.
/Rossman, William/
William M. Rossman
Examing Attorney
Law Office 109
571-272-9029
William.Rossman@uspto.gov
RESPONSE GUIDANCE
