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:  March 24, 2020

 

 INTRODUCTION

 

This Office action is in response to applicant’s communication filed on February 29, 2020.

 

In a previous Office action(s) dated August 29, 2019, the trademark examining attorney refused registration of the applied-for mark based on the following:  CSA and FDCA Refusals and Specimen Refusal.  In addition, applicant was required to satisfy the following requirement(s):  identification amendment, mark significance inquiry, and information about goods requirements.

 

Based on applicant’s response, the trademark examining attorney notes that the following requirement(s) have been satisfied: mark significance inquiry, and information about goods requirements.  See TMEP §§713.02, 714.04. 

 

In addition, the following refusal(s) and/or requirement(s) have been withdrawn:  CSA and Specimen Refusals.  See TMEP §§713.02, 714.04. 

 

Further, the trademark examining attorney maintains and now makes FINAL the refusal(s) and/or requirement(s) in the summary of issues below.  See 37 C.F.R. §2.63(b); TMEP §714.04.

 

SUMMARY OF ISSUES MADE FINAL that applicant must address:

• FDCA Refusal
• Identification Amendment Required
• Partial Abandonment – Advisory

 

 

I.         PARTIAL FDCA REFUSAL

 

Please note that this refusal applies only to applicant’s Class 005 and 029 goods.

 

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 copy previously 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, Dietary supplements in the form of capsules, edible sheets, extracts, waxes, live resin, resin; Nutritional supplements in the form of oils, fats, herbs, dried plant, concentrates, waxes, edibles, capsule, dissolving sheets; Edible fats; Edible oil; Edible oils; Edible oils and fats; all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.

The wording contained in the identification in addition to applicant’s response to the request for information plainly indicates that applicant’s identified goods/services include items and/or activities that are prohibited by the FDCA, namely, because the aforementioned goods contain 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 copy previously attached.  Additional attached evidence from the FDA’s website indicates that they have not changed their stance on added CBD.  Moreover applicant points to Question 9 of FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD) http://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#dietarysupplements where “There is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable.”  Applicant, however, neglected the next sentence of that exception, which is “However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”  This answer goes on to note that “Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements.”  Because applicant’s response clearly indicated that the goods contain CBD, and more than trace amounts (as indicated by the specimen), they are currently illegal.

 

Further, applicant’s identification also includes pharmaceuticals and/or topicals to which the proposed mark are applied were unlawful under the federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. §321(g)(1).   Applicant’s goods and/or services include items that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and/or intended to affect the structure of or any function of the body, namely, “Inhalant anesthetics; Transdermal patches featuring hemp extracts for anxiety, post-traumatic stress disorder (PTSD), appetite suppresant, cancer; Transdermal patches; Drug delivery agents in the form of capsules that provide controlled release of the active ingredients for a wide variety of pharmaceuticals; Herbal extracts for medical purposes; Medicinal herb extracts; Medicinal preparations for the mouth to be applied in the form of drops, capsules, tablets and compressed tablets; Plant extracts for medical, veterinary and pharmaceutical purposes; Plant extracts for pharmaceutical purposes; all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis.  Furthermore, the applicant’s response to the request for information indicates that these products include more than a trace amount of CBD. 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 mark in commerce without FDA approval would be unlawful use in commerce.

 

In the event applicant is currently seeking FDA approval of the marketing of its goods, applicant may submit a copy of its marketing application and amend the filing basis of the application to claim a bona fide intent to use the mark in commerce under Section 1(b), 15 U.S.C. §1051(b), until such time as applicant’s application is approved, and lawful use may be alleged.  

 

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.

 

 

II.        IDENTIFICATION AMENDMENT REQUIRED

 

The wording “Edible fats; Edible oil; Edible oils; Edible oils and fats, all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis” in the identification of goods is indefinite and must be clarified based on the punctuation.  Specifically, as it currently reads, “all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis” only applies to the last good “edible oils and fats.”  If the “all of the foregoing” language actually applies to every good in that class, applicant should amend the comma to a semi-colon.  If the “all of the foregoing” language applies to only that last good, due to the nature of applicant’s goods, applicant must explicitly note that the remainder of the goods do not contain any hemp.  Applicant must similarly do this with Class 031.

 

If accurate, applicant may adopt the following identification in their appropriate international classes:

 

International Class 003: Essential oils; Essential oils for personal use; Terpenes being essential oils; all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis

 

International Class 005: Inhalant anesthetics; Transdermal patches featuring hemp extracts for anxiety, post-traumatic stress disorder (PTSD), appetite suppressant {fixed typo}, cancer; Transdermal patches; Dietary supplements in the form of capsules, edible sheets, extracts, waxes, live resin, resin; Drug delivery agents in the form of capsules that provide controlled release of the active ingredients for a wide variety of pharmaceuticals; Herbal extracts for medical purposes; Medicinal herb extracts; Medicinal preparations for the mouth to be applied in the form of drops, capsules, tablets and compressed tablets; Nutritional supplements in the form of oils, fats, herbs, dried plant, concentrates, waxes, edibles, capsule, dissolving sheets; Plant extracts for medical, veterinary and pharmaceutical purposes; Plant extracts for pharmaceutical purposes; all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis

 

International Class 029: Edible fats; Edible oil; Edible oils; Edible oils and fats; {added semicolon, otherwise applicant must indicate “edible fats, edible oil, edible oils, all the foregoing not containing cannabis, hemp, CBD, or any extracts or derivatives thereof; edible oils and fats, all of the foregoing containing hemp with a….”} all of the foregoing containing hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis

 

International Class 031: Dried plants excluding cannabis with a delta-9 tetrahydrocannabinol (THC) concentration of greater than 0.3 percent on a dry weight basis; Dried plants, namely, hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis

 

An applicant may only amend an identification to clarify or limit the goods, but not to add to or broaden the scope of the goods.  37 C.F.R. §2.71(a); see TMEP §§1402.06 et seq., 1402.07.

 

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 at http://tess2.gov.uspto.report/netahtml/tidm.html.  See TMEP §1402.04.

 

 

III.      PARTIAL ABANDONMENT – ADVISORY

 

If applicant does not respond to this Office action within the six-month period for response, the following goods will be deleted:  Classes 005 and 029 and “dried plants” in Class 031.  The application will then proceed with the following goods only:  Class 003 and “Dried plants, namely, hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis” in Class 031.  See 37 C.F.R. §2.65(a)-(a)(1); TMEP §718.02(a).

 

 

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).

 

 

/Elle Marino/

Trademark Examining Attorney

Law Office 121

Phone: (571) 270-3699

E-mail: elle.marino@uspto

 

 

 

 

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 March 24, 2020 for

U.S. Trademark Application Serial No. 88245193

 

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. 

 

 

/Elle Marino/

Trademark Examining Attorney

Law Office 121

Phone: (571) 270-3699

E-mail: elle.marino@uspto

 

 

 

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 March 24, 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.”