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:  November 13, 2019

 

The Office has reassigned this application to the undersigned trademark examining attorney.

 

The statement of use and Petition to Revive has been reviewed by the assigned trademark examining attorney.  Applicant must respond timely and completely to the issues below.  15 U.S.C. §1062(b); 37 C.F.R. §§2.62(a), 2.65(a); TMEP §§711, 718.03.

 

SUMMARY OF ISSUES

• CSA Refusal
• FDCA Refusal
• Specimen Requirement – Specimen Unacceptable
• Request for Information

 

CSA REFUSAL

 

Registration is refused because the applied-for mark was 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 with which the proposed mark will be used were unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971, as of 06/22/2018, the date on which the application was filed.  Applicant’s goods are broad enough to encompass products that consist of, or include, items or activities that are or were prohibited by the CSA, namely, “Skin and body topical lotions, creams and oils for cosmetic use” and “Dietary and nutritional supplements”. As evidenced by applicant’s specimen of record, the broadly stated identified goods contain CBD.

 

Cannabidiol (CBD) is a chemical constituent of the cannabis plant that is encompassed within the CSA’s definition of marijuana.  See Clarification of the New Drug Code (7350) for Marijuana Extract, http://www.deadiversion.usdoj.gov/schedules/marijuana/m_extract_7350.html, copy attached; see also, 21 C.F.R. §1308.11(d)(58).  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). 

 

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).  The goods identified did not potentially comply with applicable federal laws until that date.  Because the identified goods and/or services consist of or include items or activities that are or were prohibited under the Controlled Substances Act, the applicant did not have a valid basis for filing the application.  Nevertheless, to the extent the applicant’s goods contain CBD derived from cannabis plants that meet the current statutory definition of hemp, the goods may presently be lawful.

 

Due to the changed circumstances and the potential lawfulness of certain products and activities that meet the definition of the Agricultural Marketing Act of 1946, as amended (AMA), applicant may request to amend the filing date of the current application to be December 20, 2018.  See Examination Guide 1-19 Examination of Marks for Cannabis and Cannabis-Related Goods and Services after Enactment of the 2018 Farm Bill http://www.gov.uspto.report/sites/default/files/documents/Exam%20Guide%201-19.pdf. Applicant must specifically state for the record that such a change to the filing date is being authorized and must establish a valid filing basis under 37 C.F.R. §2.34 by satisfying the relevant requirements. See 37 C.F.R. §§2.34 et seq., TMEP §§806 et seq.  In the event of such an amendment, the undersigned examining attorney will conduct a new search of the USPTO records for conflicting marks based on the later application filing date.  TMEP §§206.01, 1102.03 For instructions on how to satisfy basis requirements online using the Trademark Electronic Application System (TEAS) form, please go to the Basis webpage.

 

In addition to the foregoing, the following requirements would also need to be met:

1)      The date of first use in commerce cannot be before 12/20/18. If it is, the new use date must be verified with a declaration;

 

2)      Applicant must restate its bona fide intent to use as of the new filing date as its original statement is a legal impossibility as the Statement of Use was filed on or after 12/20/2018, the allegation of use within it is presumptively lawful; and

 

            3) Applicant will be required to amend its Identification to comply with statutory defined meaning of hemp as follows:

 

                        Class 003: Skin and body topical lotions, creams and oils for cosmetic use; all the foregoing containing cannabidiol solely derived from hemp with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis

                        Class 005:  Dietary and nutritional supplements containing cannabidiol solely derived from hemp with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis

 

In lieu of amending the filing date, applicant may elect to abandon the current application and file a new application with a new fee that will have an application filing date that is later than the enactment of the December 20, 2018 amendments to the AMA. Alternatively, applicant may respond to the stated refusal by submitting evidence and arguments against the refusal.

 

However, applicant should note the amendment indicated above will not obviate the FDCA Refusal below as regardless of whether a substance is hemp-derived, it is the FDA’s current view that it is unlawful to market goods to be ingested containing any cannabinoids or to market goods that have a therapeutic or medical use, or any product that is intended to affect the structure or function of the body of humans or animals.

 

FDCA REFUSAL

 

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 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).

 

Applicant’s goods are broad enough to encompass products that consist of, or include, items or activities that are prohibited by the FDCA, namely, supplements and oral tinctures. The specimen of record plainly indicates that applicant’s goods 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. 

 

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 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.

 

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

 

SPECIMEN REQUIREMENT – SPECIMEN UNACCEPTABLE

 

THIS PARTIAL REQUIREMENT APPLIES TO CLASS 003 ONLY

 

Registration is refused because the specimen does not show the applied-for mark in use in commerce in connection with any of the goods specified in International Class 003 in the statement of use.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; 37 C.F.R. §§2.34(a)(1)(iv), 2.56(a); In re Keep A Breast Found., 123 USPQ2d 1869, 1876-79 (TTAB 2017); In re Graystone Consulting Assocs., Inc., 115 USPQ2d 2035, 2037-38 (TTAB 2015); TMEP §§904, 904.07(a), 1301.04(d), (g)(i). 

 

Specifically, applicant has applied for the mark NAVAN in connection with “Skin and body topical lotions, creams and oils for cosmetic use”. However, the specimen consists of the mark on a bottle of oral tinctures which are classified in Class 005. Applicant’s own website supports this contention by demonstrating that the specimen is a tincture that is to be taken 1-3 times daily “in a glass of spring or filtered water” for therapeutic/medical purposes. See attached screenshots from http://navanglobal.com/product/daily-detox/. Therefore, the mark is not shown in use in commerce with any of the class 003 goods.

 

An application based on Trademark Act Section 1(a) must include a specimen showing the applied-for mark in use in commerce for each international class of goods and/or services identified in the statement of use.  15 U.S.C. §1051(a)(1); 37 C.F.R. §§2.34(a)(1)(iv), 2.56(a); TMEP §§904, 904.07(a); see In re Gulf Coast Nutritionals, Inc., 106 USPQ2d 1243, 1247 (TTAB 2013).

 

Examples of specimens for goods include tags, labels, instruction manuals, containers, photographs that show the mark on the actual goods or packaging, and displays associated with the actual goods at their point of sale.  See TMEP §§904.03 et seq.  Webpages may also be specimens for goods when they include a picture or textual description of the goods associated with the mark and the means to order the goods.  TMEP §904.03(i).  Examples of specimens for services include advertising and marketing materials, brochures, photographs of business signage and billboards, and webpages that show the mark used in the actual sale, rendering, or advertising of the services.  See TMEP §1301.04(a), (h)(iv)(C).  Specimens comprising advertising and promotional materials must show a direct association between the mark and the services.  TMEP §1301.04(f)(ii).

 

Applicant may respond to this refusal by submitting, for each applicable international class, a different specimen (a verified “substitute” specimen) that (a) was in actual use in commerce prior to the expiration of the deadline for filing the statement of use and (b) shows the mark in actual use in commerce for the goods and/or services identified in the statement of use.  A “verified substitute specimen” is a specimen that is accompanied by the following statement made in a signed affidavit or supported by a declaration under 37 C.F.R. §2.20:  “The substitute (or new, or originally submitted, if appropriate) specimen(s) was/were in use in commerce prior to expiration of the filing deadline for a statement of use.”  The substitute specimen cannot be accepted without this statement.

 

Applicant, however, may not withdraw the statement of use.  See 37 C.F.R. §2.88(f); TMEP §1109.17.

 

For more information about this refusal and instructions on how to submit a verified “substitute” specimen online using the Trademark Electronic Application System (TEAS) form, please go to http://www.gov.uspto.report/trademarks/law/specimen.jsp.

 

REQUEST FOR INFORMATION

 

Applicant must submit a written statement indicating whether all the goods/services identified in the application comply with the Controlled Substances Act (CSA) , 21 U.S.C. §§801-971 (see questions below). See 37 C.F.R. §2.69; TMEP §907. The CSA prohibits, among other things, manufacturing, distributing, dispensing, or possessing certain controlled substances, including marijuana and marijuana-based preparations. 21 U.S.C. §§812, 841(a)(1), 844(a); see also 21 U.S.C. §8 02(16) (defining “[marijuana]”). The CSA also makes it unlawful to sell, offer for sale, or use any facility of interstate commerce to transport drug paraphernalia, i.e., “any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under [the CSA].” 21 U.S.C. §863.

 

In addition, applicant must submit a written statement indicating whether the goods/services identified in the application comply with the Food, Drug and Cosmetic Act (FDCA). 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).   See 37 C.F.R. §2.69; TMEP §907. Furthermore, 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).

 

Lastly, Applicant must provide written responses to the following questions:

 

1. Do or will applicant’s identified goods include any oils, extracts, ingredients or derivatives from the plant Cannabis sativa L (also known as cannabis, marijuana or hemp)?

 

2. If the answer to Question 1 is “yes,” does the hemp used or to be used in applicant’s goods contain more than 0.3 percent delta-9 tetrahydrocannabinol (THC) on a dry weight basis?

 

3. If applicant has any documentation relative to the THC content of the oils, extracts or derivatives used or to be used in the goods, please submit them with the response.

 

4. If applicant’s goods do or will contain oils, extracts, ingredients or derivatives from the plant Cannabis sativa L which has more than 0.3 percent delta-9 tetrahydrocannabinol on a dry weight basis, identify the part or parts of the plant used in obtaining the oils, extracts, ingredients or derivatives.

 

5. Do or will the goods include cannabidiol (CBD)?

 

6. If so, will there be more than a trace amount of CBD in the goods, e.g., more than 50 parts per million (PPM)?

 

7. Do or will applicant’s identified goods include CBD which is derived from, oils, extracts or ingredients from plants other than Cannabis sativa L (also known as hemp, marijuana or cannabis)

 

8. Is applicant currently seeking FDA approval of the marketing of its goods identified in the application?

 

9. If the answer to Question 8 is “yes,” please provide a copy of such application

 

Failure to comply with a request for information is grounds for refusing registration.  In re Harley, 119 USPQ2d 1755, 1757-58 (TTAB 2016); TMEP §814.  Merely stating that information about the goods and services is available on applicant’s website is an insufficient response and will not make the relevant information of record.  See In re Planalytics, Inc., 70 USPQ2d 1453, 1457-58 (TTAB 2004).

 

ASSISTANCE

 

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  

 

 

/Heather A. Sales/

Examining Attorney

Law Office 122

(571) 272-7835

Heather.Sales@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 13, 2019 for

U.S. Trademark Application Serial No. 88010796

 

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. 

 

 

/Heather A. Sales/

Examining Attorney

Law Office 122

(571) 272-7835

Heather.Sales@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 13, 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.”