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:  April 01, 2020

 

 

This Final Office action is in response to applicant’s communication filed on 03/19/2020 (“Response”) in which applicant addressed the following issues:

 

1.      Refusal under Trademark Act Sections 1 and 45 - CSA Refusal

2.      Refusal under Trademark Act Sections 1 and 45 - FDCA Refusal

3.      Requirement for Information on Goods

4.      Requirement for Information on Attorney

 

Items 1, 3, and 4 are acceptable and made part of the record; the related requirements are therefore satisfied. 

 

With respect to Item 2, the examining attorney has carefully considered the applicant's arguments/amendments but has found them unpersuasive.  For the reasons set forth below, the refusal is now made FINAL.  See 37 C.F.R. §2.63(b).

 

FDCA REFUSAL

 

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. 

 

To qualify for federal trademark 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 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 items listed in the application in connection with which the mark is intended to be used 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 previously attached.

 

In the present case, the application identifies applicant’s goods as follows: Dietary and nutritional supplements containing cannabidiol (CBD) derived solely from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis. The prior attachments from applicant’s website http://precisionbotanical.com/our-products/ plainly indicates that applicant’s supplements contain CBD and that such goods are currently being marketed, promoted or offered for sale to consumers. Applicant’s Response confirms that applicant’s goods contain CBD and that applicant is not currently seeking FDA approval of its goods.

 

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.  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% tetrahydrocannabinol (THC) does not obviate this refusal. 

 

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). Applicant states in its Response,

 

Applicant is awaiting revision to the FDA regulations prior to marketing goods containing CBD derived from hemp and intended for human consumption.

 

However, 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.  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.    Therefore, the refusal is now made final.

 

Proper Response to Final Office Action

 

Applicant must respond within six months of the date of issuance of this final Office action or the application will be abandoned.  15 U.S.C. §1062(b); 37 C.F.R. §2.65(a).  Applicant may respond by providing one or both of the following:

 

(1)        A request for reconsideration that fully resolves all outstanding requirements and refusals; and/or

 

(2)        An appeal to the Trademark Trial and Appeal Board with the required filing fees.

 

TMEP §715.01; see 37 C.F.R. §2.63(b)(1)-(2).

 

Please contact 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 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).

 

 

/Ms. Tasneem Hussain/

Trademark Examining Attorney

Law Office 130

tasneem.hussain@uspto.gov (preferred)

571.272.8273

 

 

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 01, 2020 for

U.S. Trademark Application Serial No. 88297622

 

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. 

 

 

/Ms. Tasneem Hussain/

Trademark Examining Attorney

Law Office 130

tasneem.hussain@uspto.gov (preferred)

571.272.8273

 

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 01, 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.”