Offc Action Outgoing

United States Patent and Trademark Office (USPTO)

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

 

 

 

FINAL 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) and/or Electronic System for Trademark Trials and Appeals (ESTTA).  A link to the appropriate TEAS response form and/or to ESTTA for an appeal appears at the end of this Office action. 

 

Issue date:  November 02, 2020

 

 

INTRODUCTION

 

Applicant’s response of September 23, 2020, to the office action of March 28, 2020, has been reviewed and the following determinations have been made.

 

Upon further consideration, the Section 2d refusal is withdrawn.  The Section 1 & 45 refusal based on the Food, Drug and Cosmetic Act (FDCA) is made FINAL for the reasons provided below.

 

 

Summary of Issues made FINAL:

 

·       FDCA Refusal

 

FINAL - FDCA REFUSAL – NO BONA FIDE INTENT TO LAWFULLY USE IN COMMERCE AS OF FILING DATE

 

In the previous office action, registration was refused because applicant did not have a bona fide intent to lawfully use the applied-for mark 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.  Applicant’s arguments have been considered, however, the refusal is made FINAL for the reasons provided below.

 

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/services to which the mark is to be 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 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 with content current as of October 1, 2020.

 

 

In this case, applicant’s goods are broad enough to encompass products that consist of, or include, items that are or were prohibited by the FDCA, namely, bottled water containing hemp; fruit flavored water containing hemp; fruit flavored bottled water containing hemp. In particular, as currently worded, the reference to “hemp” in the identification is broad enough to include CBD which is a hemp extract.

 

Moreover, the attachments from applicant’s website http://thealkalinewaterco.com/ plainly indicate that applicant’s identified goods include beverages containing CBD.  (See attachments in the previous office action).  Specifically, the attachments show that applicant is advertising/marketing products containing CBD. Additionally, applicant has stated in its February 14, 2020 response to office action, that at least some of the goods will contain 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 compounds. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm  copy previously 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)  Because introduction of such goods into commerce was not lawful as of the filing date, applicant did not have a bona fide intent to use the applied-for mark in lawful commerce in connection with such goods and/or the identified services.  See e.g. In re JJ206, LLC, 120 USPQ2d 1568, 1569 (TTAB 2016) (“where the identified goods are illegal under the federal Controlled Substances Act (CSA), the applicant cannot use its mark in lawful commerce, and ‘it is a legal impossibility’ for the applicant to have the requisite bona fide intent to use the mark.”); see also In re Brown, 119 USPQ2d, 1351-1352; TMEP §907.   

 

 

Response to Applicant’s Arguments:

 

In response to this refusal, applicant requests that the application be suspended “pending promised regulatory action by the Food and Drug Administration (“FDA”).   Applicant argues that good and sufficient cause exists to suspend further action because the FDA has promised regulatory action with respect to cannabis-derived products. 

 

Applicant request for suspension is denied because the request is based on a speculative future event that may or may not occur.  In this case, the request to suspend the application is based on “promised” regulatory action by the FDA and relies on an indefinite event the outcome of which is uncertain.  In particular, applicant has not shown that the FDA has begun a regulatory process, nor has applicant provided evidence of proposed regulations. 

 

By contrast, the information and statements that have been provided by the FDA at this point in time make clear that it is “unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce.” (See Statement from FDA Commissioner Scott Gottlieb, M.D previously attached).  Here, applicant’s goods are beverages which are include within the definition of “food” and the record indicates that they contain CBD.  Therefore, as per the FDA’s current position, the goods violate the FDCA and cannot be introduced into interstate commerce.  The mere possibility that the FDA may change this position in the future does not amount to a “good and sufficient cause” upon which to grant suspension.

 

Accordingly, the refusal is continued and made final.

 

 

How to respond.  Click to file a request for reconsideration of this final Office action that fully resolves all outstanding requirements and refusals and/or click to file a timely appeal to the Trademark Trial and Appeal Board (TTAB) with the required filing fee(s).

 

 

 

/Deborah Lobo/

Trademark Examining Attorney

Law Office 109

571-272-3263

deborah.lobo@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 November 02, 2020 for

U.S. Trademark Application Serial No. 88229942

 

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. 

 

 

/Deborah Lobo/

Trademark Examining Attorney

Law Office 109

571-272-3263

deborah.lobo@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 November 02, 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.”