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:  April 22, 2020

 

 

The assigned trademark examining attorney has reviewed the referenced application and has determined the following:

 

 

NO SIMILAR MARKS

 

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.

 

 

Applicant, however, should note the following refusals.

 

 

SECTIONS 1 AND 45 REFUSAL – VIOLATION OF THE CONTROLLED SUBSTANCES ACT

 

Registration is refused because the applied-for mark encompasses goods that were not in lawful use in commerce as of the filing date of the application.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see TMEP §907. 

 

To qualify for federal trademark/service mark registration, the use of a mark in commerce must be lawful.  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; see In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968); Coahoma Chemical Co., Inc. v. Smith, 113 USPQ 413 (Com’r Pat. & Trademarks 1957) (concluding that “use of a mark in connection with unlawful shipments in interstate commerce is not use of a mark in commerce which the [Office] may recognize.”).  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. 

 

Here, the items or activities to which the proposed mark are applied include those that are unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971.  Applicant’s identified goods and/or services consist of, or include, items or activities that are prohibited by the CSA, namely, “Pharmaceutical preparations for , namely, topical balms for relief of aches, pains, and anxiety; Pharmaceutical preparations, namely, topical balms containing cannabidiol (CBD) for relief of aches, pains, and anxiety; Topical analgesics containing CBD; Herbal tinctures for medical purposes containing CBD; Pharmaceutical preparations, namely, topical balms containing cannabidiol (CBD) derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources for relief of aches, pains, and anxiety; Topical analgesics containing CBD derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources; Herbal tinctures for medical purposes containing CBD derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources; Inhalers filled with pharmaceutical preparations containing CBD.” 

 

Cannabidiol (CBD) is a nonpsychoactive constituent of the cannabis plant.  Applicant’s identified goods and/or services are broad enough to include products produced from “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin” (subject to certain exceptions). 21 U.S.C. §802(16)(definition of “marihuana” – commonly referred to as “marijuana”).    

 

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)  The claimed use of the applied-for mark in connection with such goods and/or services was not in lawful commerce as of the filing date. See In re Brown, 119 USPQ2d, 1351-1352.     

 

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).  Because the identified goods and/or services that feature cannabidiol consist of or include items or activities that are still prohibited under the Controlled Substances Act, namely those containing cannabidiol derived from marijuana, the applicant did not have a valid filing basis for any such items or activities.  To the extent the applicant’s goods are derived solely from cannabis plants that meet the current statutory definition of hemp, such goods may be lawful.

 

Therefore, in order to overcome this refusal, 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 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.”  Please see the complete requirement for an acceptable identification of goods and/or services below.

 

The applicant may also present arguments and evidence against this refusal. 

 

 

SECTIONS 1 AND 45 REFUSAL – VIOLATION OF THE FOOD, DRUG AND COSMETIC ACT

 

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 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 application identifies items or activities that involve a per se violation of federal law.  See In re Brown, 119 USPQ2d at 1352.  The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of a food or beverage to which has been added a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.  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 Federal Food, Drug and Cosmetic Act). 

 

Cannabidiol (CBD) is an active ingredient in an FDA-approved drug, Epidiolex®, (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm copy attached) and is the subject of substantial clinical investigations before it was marketed in foods or as dietary supplements.  See FDA Regulation of Cannabis and Cannabis-derived Products: Questions and Answers  http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm copy attached. 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 Food, Drug and Cosmetics Act (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). 

 

In the present case, the application identifies the following goods and/or services for which applicant has alleged use in commerce: “Pharmaceutical preparations for , namely, topical balms for relief of aches, pains, and anxiety; Pharmaceutical preparations, namely, topical balms containing cannabidiol (CBD) for relief of aches, pains, and anxiety; Topical analgesics containing CBD; Herbal tinctures for medical purposes containing CBD; Pharmaceutical preparations, namely, topical balms containing cannabidiol (CBD) derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources for relief of aches, pains, and anxiety; Topical analgesics containing CBD derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources; Herbal tinctures for medical purposes containing CBD derived solely from the mature stalks and sterilized seeds of the hemp plant and from non-hemp sources; Inhalers filled with pharmaceutical preparations containing CBD.”

 

It is unlawful to introduce food or beverages containing added CBD into interstate commerce or to market CBD as, or in, dietary supplements, regardless of whether the substances are hemp-derived.  See 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 copy attached. 

 

In addition, 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 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.

 

 

Although applicant’s mark has been refused registration, applicant may respond to the refusals by submitting evidence and arguments in support of registration.  However, if applicant responds to the refusals, applicant must also respond to the requirements set forth below.

 

 

IDENTIFICATION OF GOODS

 

The identification of goods is indefinite and must be clarified because the nature of all of the goods is not clear and the wording may include ingredients derived from unlawful sources.  Additionally, applicant should note that CBD does not naturally occur in the mature stalks and seeds.  As such, this wording is indefinite.  See 37 C.F.R. §2.32(a)(6); TMEP §1402.01.  Applicant must amend the identification to specify the common commercial or generic name of the goods.  See TMEP §1402.01.  If the goods have no common commercial or generic name, applicant must describe the product, its main purpose, and its intended uses.  See id.

 

Applicant may adopt the following wording, if accurate: 

 

“Pharmaceutical preparations, namely, topical balms for relief of aches, pains, and anxiety solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis and not containing CBD” in International Class 005.

 

Applicant should note that it must delete all unapproved pharmaceutical goods containing CBD for the application to move forward.  Additionally, applicant should note that the suggested identification would require submission of a new specimen.

 

Applicant’s goods and/or services may be clarified or limited, but may not be expanded beyond those originally itemized in the application or as acceptably amended.  See 37 C.F.R. §2.71(a); TMEP §1402.06.  Applicant may clarify or limit the identification by inserting qualifying language or deleting items to result in a more specific identification; however, applicant may not substitute different goods and/or services or add goods and/or services not found or encompassed by those in the original application or as acceptably amended.  See TMEP §1402.06(a)-(b).  The scope of the goods and/or services sets the outer limit for any changes to the identification and is generally determined by the ordinary meaning of the wording in the identification.  TMEP §§1402.06(b), 1402.07(a)-(b).  Any acceptable changes to the goods and/or services will further limit scope, and once goods and/or services are deleted, they are not permitted to be reinserted.  TMEP §1402.07(e).

 

For assistance with identifying and classifying goods and services in trademark applications, please see the USPTO’s online searchable U.S. Acceptable Identification of Goods and Services Manual.  See TMEP §1402.04.

 

 

ADDITIONAL PER CLASS FEE REQUIRED

 

Processing fee required.  Applicant must submit an additional processing fee of $125 per class because the application as filed did not meet the TEAS Plus application filing requirements.  See 37 C.F.R. §2.22(a)(7), (c); TMEP §§819.01(g), 819.04.  Specifically, the application did not include only identifications of goods and/or services from the U.S. Acceptable Identification of Goods and Services Manual.  TMEP §819.01(g); see 37 C.F.R §2.22(a)(7). 

 

In this case, the application identified one or more goods and/or services from the ID Manual that used a fill-in-the-blank format.  However, applicant inserted wording in the identification that is clearly inappropriate or unrelated to the selected goods and/or services.  By inserting inappropriate wording, applicant has, in effect, failed to submit an identification from the ID Manual and thus did not satisfy this application filing requirement.  See 37 C.F.R §2.22(a)(7); TMEP §819.01(g). 

 

The additional processing fee is required regardless of whether applicant satisfies this requirement by properly filling in the blank and/or deleting the unacceptable wording in the identification.  TMEP §819.01(g).

 

Accordingly, the application will no longer be treated as TEAS Plus; it is now considered a TEAS Standard application. 

 

 

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. 

 

 

 

/Robert J. Struck/

Robert J. Struck

Trademark Examining Attorney

Law Office 109

Robert.Struck@uspto.gov

571-272-1513

 

 

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

 

 

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 April 22, 2020 for

U.S. Trademark Application Serial No. 88390863

 

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. 

 

 

/Robert J. Struck/

Robert J. Struck

Trademark Examining Attorney

Law Office 109

Robert.Struck@uspto.gov

571-272-1513

 

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 April 22, 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.”