Offc Action Outgoing

United States Patent and Trademark Office (USPTO)

Office Action (Official Letter) About Applicant’s Trademark Application

 

 

 

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:  June 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.

 

Search Results

The trademark examining attorney searched the USPTO database of registered and pending marks and found no conflicting marks that would bar registration under Trademark Act Section 2(d).  15 U.S.C. §1052(d); TMEP §704.02.

 

FDCA Refusal

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 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

See copy attached.

 

Applicant’s goods and/or services are broad enough to encompass products that consist of, or include, items or activities that are or were prohibited by the FDCA, namely, edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement, for use as a nutritional food additive, and for use in beverages and foodstuffs; Gummies containing CBD; Capsules containing CBD; Salves containing CBD; Tinctures containing CBD.

The specimen of record plainly indicates that applicant’s identified goods/services include items and/or activities that are prohibited by the FDCA, namely, edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement, for use as a nutritional food additive, and for use in beverages and foodstuffs; Gummies containing CBD; Capsules containing CBD; Salves containing CBD; Tinctures containing CBD and that such goods are currently being marketed, promoted or offered for sale to consumers.

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 compounds.

 

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm

See copy attached.

 

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 violate federal law, the applied-for mark as used in connection with such goods and/or services is not in lawful use in commerce.

 

CONTROLLED SUBSTANCES ACT Compliance Advisory

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.

 

Cannabidiol (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. 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).

 

Applicant’s identified goods and/or services include: edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement, for use as a nutritional food additive, and for use in beverages and foodstuffs; Gummies containing CBD; Capsules containing CBD; Salves containing CBD; Tinctures containing CBD. These goods do not specify the source of the CBD contained therein.  Thus, the application includes items or activities that would still be prohibited under the CSA, namely those including CBD derived from marijuana.  Therefore, applicant would not have a valid filing basis for any such items or activities. 

 

To the extent applicant’s goods are derived solely from cannabis plants that meet the current statutory definition of “hemp,” such goods may be lawful.

 

Applicant must amend the identification of goods and services to specify that all cannabidiol-containing items are “solely derived from hemp with a delta-9 tetrahyrocannabinol (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/services accordingly:

 

“edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement, for use as a nutritional food additive, and for use in beverages and foodstuffs; Gummies containing CBD; Capsules containing CBD; Salves containing CBD; Tinctures containing CBD; all of the foregoing containing ingredients solely derived from hemp with a delta-9 tetrahyrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis”

 

Or

 

“edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement, for use as a nutritional food additive, and for use in beverages and foodstuffs; Gummies containing CBD; Capsules containing CBD; Salves containing CBD; Tinctures containing CBD; any CBD in the goods being solely derived from hemp with a delta-9 tetrahyrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis”

 

Applicant is advised that failure to amend the identification of goods/services will be grounds for refusal on the basis that the mark, as used/intended to be used in connection with the identified goods/services, is not lawful use in commerce under the CSA.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see TMEP §907.   

 

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).

 

Identification of Goods

The wording “edible hemp oil” in the identification of goods is indefinite and too broad and must be clarified.  See 37 C.F.R. §2.32(a)(6); TMEP §§1402.01, 1402.03.  In particular, this wording could encompass “edible oils” in International Class 29 and “essential oils for food flavorings” in International Class 30.  See TMEP §1402.01, 1402.03.

 

The following amended wording is suggested, if accurate:

 

• Edible hemp oil with naturally occurring cannabidiol (CBD) for use as a dietary and nutritional supplement; Hemp oil for use as an additive to foods for medical purposes; Beverages containing hemp oil for use as a nutritional supplement; Medicated supplements containing hemp oil for foodstuffs for humans; Dietary supplements in gummy, capsule, or tincture form containing CBD; Medicated salves containing CBD; all of the foregoing containing CBD derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis (INT. CLASS 5)

 

Identifications of goods and/or services can be amended only to clarify or limit the goods and/or services; adding to or broadening the scope of the goods and/or services is not permitted.  37 C.F.R. §2.71(a); see TMEP §§1402.06 et seq., 1402.07.  Therefore, applicant may not amend the identification to include goods and/or services that are not within the scope of the goods and/or services set forth in the present identification.

 

For assistance with identifying and classifying goods and/or services in trademark applications, please see the online searchable Manual of Acceptable Identifications of Goods and Services at http://tess2.gov.uspto.report/netahtml/tidm.html.  See TMEP §1402.04.

 

Information About Goods Required

To permit proper examination of the application, applicant must submit a written statement indicating whether all the goods and/or services identified in the application comply with the Controlled Substances Act (CSA), 21 U.S.C. §§801-971 (see questions below). See 37 C.F.R. §2.69; TMEP §907. The CSA prohibits, among other things, manufacturing, distributing, dispensing, or possessing certain controlled substances, including marijuana and marijuana-based preparations. 21 U.S.C. §§812, 841(a)(1), 844(a); see also 21 U.S.C. §8 02(16) (defining “[marijuana]”). The CSA also makes it unlawful to sell, offer for sale, or use any facility of interstate commerce to transport drug paraphernalia, i.e., “any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under [the CSA].” 21 U.S.C. §863.

 

The requested information should include fact sheets, instruction manuals, brochures, and/or advertisements. If these materials are unavailable, applicant should submit similar documentation for goods and/or services of the same type, explaining how its own product or services will differ.  If the goods and/or services feature new technology and no information regarding competing goods and/or services is available, applicant must provide a detailed factual description of the goods and/or services.

 

Factual information about the goods and/or services must clearly indicate what the goods and/or services are and how they are rendered, their salient features, and their prospective customers and channels of trade. Conclusory statements will not satisfy this requirement for information.

 

In addition, applicant must answer the questions below:

 

1)     If applicant has any documentation relative to the CBD content of the oils, extracts or derivatives used or to be used in the goods, please submit them with the response.

2)     Do or will applicant’s identified goods include CBD which is derived from, oils, extracts or ingredients from plants other than Cannabis sativa L (also known as hemp, marijuana or cannabis)?

3)     Is applicant currently seeking FDA approval of the marketing of its goods identified in the application?

4)     If the answer to Question 3 is “yes,” please provide a copy of such application.

 

Failure to comply with a request for information is grounds for refusing registration.  In re Harley, 119 USPQ2d 1755, 1757-58 (TTAB 2016); TMEP §814.  Merely stating that information about the goods and services is available on applicant’s website is an insufficient response and will not make the relevant information of record.  See In re Planalytics, Inc., 70 USPQ2d 1453, 1457-58 (TTAB 2004).

 

Attorney Bar Information Required

Applicant’s attorney must provide the following bar information:  (1) his or her bar membership number, if the bar provides one; (2) the name of the U.S. state, commonwealth, or territory of his or her bar membership; and (3) the year of his or her admission to the bar.  37 C.F.R. §2.17(b)(3).  This information is required for all U.S.-licensed attorneys who are representing trademark applicants at the USPTO.  Id.  If the attorney’s bar does not issue bar membership numbers, applicant must state this for the record.  See id.

 

To provide bar information.  Applicant’s attorney should respond to this Office action by using the appropriate TEAS response form and provide his or her bar information in the “Attorney Information” page of the form, within the bar information section.  See 37 C.F.R. §2.17(b)(1)(ii).  Bar information provided in any other area of the form will be viewable by the public in USPTO records.

 

Response Guidelines

For this application to proceed, applicant must explicitly address each refusal and/or requirement in this Office action.  For a refusal, applicant may provide written arguments and evidence against the refusal, and may have other response options if specified above.  For a requirement, applicant should set forth the changes or statements.  Please see “Responding to Office Actions” and the informational video “Response to Office Action” for more information and tips on responding.

 

Please call or email the assigned trademark examining attorney with questions about this Office action.  Although an examining attorney cannot provide legal advice, the examining attorney can provide additional explanation about the refusal(s) and/or requirement(s) in this Office action.  See TMEP §§705.02, 709.06. 

 

The USPTO does not accept emails as responses to Office actions; however, emails can be used for informal communications and are included in the application record.  See 37 C.F.R. §§2.62(c), 2.191; TMEP §§304.01-.02, 709.04-.05. 

 

How to respond.  Click to file a response to this nonfinal Office action.    

 

 

/Emily Chuo/

Trademark Examining Attorney

Law Office 130

U.S. Patent & Trademark Office

Phone:  571.272.1728

Emily.Chuo@uspto.gov

 

 

RESPONSE GUIDANCE

• Missing the response deadline to this letter will cause the application to abandon.  A response or notice of appeal must be received by the USPTO before midnight Eastern Time of the last day of the response period.  TEAS and ESTTA maintenance or unforeseen circumstances could affect an applicant’s ability to timely respond.  

 

• Responses signed by an unauthorized party are not accepted and can cause the application to abandon.  If applicant does not have an attorney, the response must be signed by the individual applicant, all joint applicants, or someone with legal authority to bind a juristic applicant.  If applicant has an attorney, the response must be signed by the attorney.

 

• If needed, find contact information for the supervisor of the office or unit listed in the signature block.

 

United States Patent and Trademark Office (USPTO)

 

USPTO OFFICIAL NOTICE

 

Office Action (Official Letter) has issued

on June 11, 2020 for

U.S. Trademark Application Serial No. 88432030

 

Your trademark application has been reviewed by a trademark examining attorney.  As part of that review, the assigned attorney has issued an official letter that you must respond to by the specified deadline or your application will be abandoned.  Please follow the steps below.

 

(1)  Read the official letter.

 

(2)  Direct questions about the contents of the Office action to the assigned attorney below. 

 

 

/Emily Chuo/

Trademark Examining Attorney

Law Office 130

U.S. Patent & Trademark Office

Phone:  571.272.1728

Emily.Chuo@uspto.gov

 

Direct questions about navigating USPTO electronic forms, the USPTO website, the application process, the status of your application, and/or whether there are outstanding deadlines or documents related to your file to the Trademark Assistance Center (TAC).

 

(3)  Respond within 6 months (or earlier, if required in the Office action) from June 11, 2020, using the Trademark Electronic Application System (TEAS).  The response must be received by the USPTO before midnight Eastern Time of the last day of the response period.  See the Office action for more information about how to respond

 

 

 

GENERAL GUIDANCE

·       Check the status of your application periodically in the Trademark Status & Document Retrieval (TSDR) database to avoid missing critical deadlines.

 

·       Update your correspondence email address, if needed, to ensure you receive important USPTO notices about your application.

 

·       Beware of misleading notices sent by private companies about your application.  Private companies not associated with the USPTO use public information available in trademark registrations to mail and email trademark-related offers and notices – most of which require fees.  All official USPTO correspondence will only be emailed from the domain “@uspto.gov.”