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:  December 11, 2019

 

INTRODUCTION

 

This Office action is supplemental to and supersedes the previous Office action issued on August 7, 2019 in connection with this application.  Based on information and/or documentation in applicant’s response, the trademark examining attorney now issues the following new refusal(s):  FDA Refusal based upon no bona fide intent.  See TMEP §§706, 711.02. 

 

In a previous Office action(s) dated August 7, 2019, the applicant was required to satisfy the following requirement(s):  amend the identification of goods and/or services, amend the classifications and answer a request for information inquiry.

 

Based on applicant’s response, the trademark examining attorney notes that the following requirement(s) have been satisfied:  definite amended identification and classifications provided and the request for information was answered.  See TMEP §713.02. Based upon applicant’s response and information provided, the following new refusal must be issued.  

 

 

 

 

 

The following is a SUMMARY OF ISSUES that applicant must address:

 

            •  NEW ISSUE:  FDA Refusal – No Bona Fide Intent

           

 

Applicant must respond to all issues raised in this Office action, within six (6) months of the date of issuance of this Office action.  37 C.F.R. §2.62(a); see TMEP §711.02.  If applicant does not respond within this time limit, the application will be abandoned.  37 C.F.R. §2.65(a).

 

FDCA Refusal - No Bona Fide Intent to Lawfully Use in Commerce as of Filing Date

 

Registration is refused because applicant does not have a bona fide intent to lawfully use the applied-for mark in commerce.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; see 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

 

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 to which the mark will 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 prohibits the introduction or delivery for introduction into interstate commerce of a food 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)  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

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, Essential oils (used as a topical) extracted from industrial hemp; Transdermal hemp patches for use in the treatment of pain, anxiety, and stress extracted from industrial hemp; and Vitamin supplement patches containing industrial hemp.

The evidence submitted in applicant’s response plainly indicates that applicant’s dietary and nutritional vitamin supplement; as well as the topicals and topical patches and topical essential oils contain CBD and that such goods are currently being marketed, promoted or offered for sale to consumers.

It is unlawful to introduce food 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. The evidence provided in applicant’s response plainly indicates that applicant’s topical analgesics, medicated patches etc., are comprised of cannabidiol and are promoted to have therapeutic or medical benefits that affect the structure or function of the body.

 

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 lawfully use the applied-for mark in 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. 

 

Although applicant’s mark has been refused registration, applicant may respond to the refusal(s) by submitting evidence and arguments in support of registration.

 

Please call or email the assigned trademark examining attorney with questions about this Office action.  Although the trademark examining attorney cannot provide legal advice or statements about applicant’s rights, the trademark examining attorney can provide applicant with additional explanation about the refusal(s) and/or requirement(s) in this Office action.  See TMEP §§705.02, 709.06.  Although the USPTO does not accept emails as responses to Office actions, emails can be used for informal communications and will be included in the application record.  See 37 C.F.R. §§2.62(c), 2.191; TMEP §§304.01-.02, 709.04-.05. 

 

 

TEAS PLUS OR TEAS REDUCED FEE (TEAS RF) APPLICANTS – TO MAINTAIN LOWER FEE, ADDITIONAL REQUIREMENTS MUST BE MET, INCLUDING SUBMITTING DOCUMENTS ONLINE:  Applicants who filed their application online using the lower-fee TEAS Plus or TEAS RF application form must (1) file certain documents online using TEAS, including responses to Office actions (see TMEP §§819.02(b), 820.02(b) for a complete list of these documents); (2) maintain a valid e-mail correspondence address; and (3) agree to receive correspondence from the USPTO by e-mail throughout the prosecution of the application.  See 37 C.F.R. §§2.22(b), 2.23(b); TMEP §§819, 820.  TEAS Plus or TEAS RF applicants who do not meet these requirements must submit an additional processing fee of $125 per class of goods and/or services.  37 C.F.R. §§2.6(a)(1)(v), 2.22(c), 2.23(c); TMEP §§819.04, 820.04.  However, in certain situations, TEAS Plus or TEAS RF applicants may respond to an Office action by authorizing an examiner’s amendment by telephone or e-mail without incurring this additional fee.  

 

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

 

 

 

 

 

/Mark T. Mullen/

Trademark Attorney

U.S. Patent and Trademark Office

Law Office 111

(571) 272-9201

mark.mullen@uspto.gov (informal inquiries only)

 

 

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 December 11, 2019 for

U.S. Trademark Application Serial No. 88206008

 

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. 

 

 

/Mark T. Mullen/

Trademark Attorney

U.S. Patent and Trademark Office

Law Office 111

(571) 272-9201

mark.mullen@uspto.gov (informal inquirie

 

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 December 11, 2019, 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.”