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:  September 05, 2019

 

The referenced application has been reviewed by the assigned trademark examining attorney.  Applicant must respond timely and completely to the issue(s) below.  15 U.S.C. §1062(b); 37 C.F.R. §§2.62(a), 2.65(a); TMEP §§711, 718.03.

 

SUMMARY OF ISSUES

 

1)     CBD Refusal: Not In Lawful Use In Commerce As Of Filing Date.

2)     FDCA Refusal: Not Lawful Use In Commerce.

3)     Requirement for Additional Information.

4)     Identification of Goods Requirement.

 

NO CONFLICTING MARKS NOTED

 

The trademark examining attorney has searched the Office’s database of registered and pending marks and has found no conflicting marks that would bar registration under Trademark Act Section 2(d).  TMEP §704.02; see 15 U.S.C. §1052(d).

 

CANNABIS SPECIFIED GOODS REFUSAL – NOT IN LAWFUL USE IN COMMERCE AS OF FILING DATE

 

Registration is refused because the applied-for mark encompasses goods and/or services that were 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 to which the proposed mark are applied include those that are unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971.   The application identifies the following cannabis goods and/or services: 

 

Dietary and nutritional supplements containing industrial hemp

 

Such goods 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)(definition of “marihuana” – commonly referred to as “marijuana”). 

 

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 goods featuring products that meet the definition of marijuana was not 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).  Because the identified goods consist of or include items or activities that are still prohibited under the Controlled Substances Act, the applicant did not have a valid filing basis for any such items or activities.  To the extent the applicant’s goods are derived solely from cannabis plants that meet the current statutory definition of hemp, such goods may be lawful.

 

Therefore, in order to overcome this refusal, applicant must amend the identification of goods and services to specify that all cannabis-containing items are “solely derived from hemp with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” 

 

Please see the complete requirement for an acceptable identification of goods below.

 

The applicant may also present arguments and evidence against this refusal. 

 

Applicant should note the following additional ground for refusal.

 

FDCA REFUSAL: NOT LAWFUL USE IN COMMERCE

 

Registration is further 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 application identifies items or activities that involve a per se violation of federal law.  See In re Brown, 119 USPQ2d at 1352.  The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of a food or beverage 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) 

 

In the present case, the application identifies the following goods for which applicant has alleged use in commerce: Dietary and nutritional supplements containing industrial hemp.

 

It is unlawful to introduce food or beverages 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 are a per se violation of federal law, the applied-for mark as used in connection with such goods is not in lawful use in commerce.

 

REQUIREMENT FOR ADDITIONAL INFORMATION

 

To permit proper examination of the application, applicant must submit additional information about the goods.  37 C.F.R. §§2.61(b), 2.69; Cf. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1284, 73 USPQ2d 1409, 1414 (Fed. Cir. 2005) (discussing Patent Rule 1.105(a)(1), which is the equivalent of Trademark Rule 2.61(b)); TMEP §§814, 907.  The requested information should include fact sheets, brochures, advertisements, and/or similar materials relating to the goods.  If such materials are not available, applicant must provide a detailed factual description of the goods.  Any information submitted in response to this requirement must clearly and accurately indicate the nature of the goods identified in the application. 

 

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);

 

Finally, applicant must provide written responses to the following questions:

1. Do or will the goods include cannabidiol (CBD)?
2. If so, will there be more than a trace amount of CBD in the goods, e.g., more than 50 parts per million (PPM)?
3. 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)?
4. Is applicant currently seeking FDA approval of the marketing of its goods identified in the application?
5. If the answer to Question 4 is “yes,” please provide a copy of such application.
6. 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.
7. 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.
8. If the “hemp” is grown in the United States of America, was the hemp used in the goods obtained from an authorized grower or supplier of industrial hemp from a hemp growing pilot program set up under the 2014 Farm Bill?
9. Do the applicant’s goods contain “naturally occurring trace amounts” of CBD and/or hemp?
10. Does the applicant’s goods feature hemp which is obtained from the mature stalks and sterilized seeds?
11. Upon information and belief, do applicant’s goods comply with the Controlled Substances Act?

Failure to satisfactorily respond to a requirement for information is a ground for refusing registration. See In re Harley, 119 USPQ2d 1755, 1758 (TTAB 2016) (affirming refusal of registration because applicant’s appeal brief failed to address the relevant refusals, including a refusal based on noncompliance with a requirement for information); In re AOP LLC, 107 USPQ2d 1644, 1651 (TTAB 2013) (“Failure to comply with a request for information is grounds for refusal,” where applicant provided equivocal responses to examining attorney’s questions and did not address this issue in its brief).  Applicant’s failure to respond to an information requirement may result in an adverse evidentiary inference being drawn regarding applicant’s goods. Id. at 1651; In re Cheezwhse.com, Inc., 85 USPQ2d 1917, 1919 (TTAB 2008); TMEP §814. 

 

Please note that merely stating that information about the goods and services is available on applicant’s website is an inappropriate response to the above requirement and is insufficient to make the relevant information properly of record. See In re Planalytics, Inc., 70 USPQ2d 1453, 1457-58 (TTAB 2004).

 

Applicant is advised that, upon consideration of the information provided by applicant in response to the above requirement, registration of the applied-for mark may be refused on the ground that the mark, as used/intended to be used in connection with the identified goods, is not lawful use in commerce. Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127.  Use of a mark in commerce must be lawful use to be the basis for federal registration of the mark.   Gray v. Daffy Dan’s Bargaintown, 823 F.2d 522, 526, 3 USPQ2d 1306, 1308 (Fed. Cir. 1987); see 15 U.S.C. §§1051, 1127; 37 C.F.R. §2.69; In re Midwest Tennis & Track Co., 29 USPQ2d 1386, 1386 n.2 (TTAB 1993); In re Stellar Int’l, Inc., 159 USPQ 48, 50-51 (TTAB 1968); TMEP §907.

 

IDENTIFICATION OF GOODS

 

The identification of goods is indefinite and must be clarified because as worded, the exact nature of the goods are is unclear.  Where indicated, the applicant must specify the exact nature of the goods by its common commercial name.  See 37 C.F.R. §2.32(a)(6); TMEP §1402.01.  The suggested changes are in bold.

 

Applicant may adopt the following identification, if accurate: 

 

“Dietary and nutritional supplements containing industrial hemp; the foregoing solely derived from hemp with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis,” in International Class 5. 

 

Applicant may amend the identification to clarify or limit the goods, but not to broaden or expand the goods beyond those in the original application or as acceptably amended.  See 37 C.F.R. §2.71(a); TMEP §1402.06.  Generally, any deleted goods may not later be reinserted.  See TMEP §1402.07(e).

 

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.  See TMEP §1402.04.

 

RESPONSE GUIDELINES

 

For this application to proceed, applicant must explicitly address each refusal and/or requirement in this Office action.  For a refusal, applicant may provide written arguments and evidence against the refusal, and may have other response options if specified above.  For a requirement, applicant should set forth the changes or statements.  Please see “Responding to Office Actions” and the informational video “Response to Office Action” for more information and tips on responding.

 

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. 

 

Because of the legal technicalities and strict deadlines involved in the USPTO application process, applicant may wish to hire a private attorney specializing in trademark matters to represent applicant in this process and provide legal advice.  Although the undersigned trademark examining attorney is permitted to help an applicant understand the contents of an Office action as well as the application process in general, no USPTO attorney or staff is permitted to give an applicant legal advice or statements about an applicant’s legal rights.  TMEP §§705.02, 709.06. 

 

For attorney referral information, applicant may consult the American Bar Association’s Consumers’ Guide to Legal Help at http://www.abanet.org/legalservices/findlegalhelp/home.cfm, an attorney referral service of a state or local bar association, or a local telephone directory.  The USPTO may not assist an applicant in the selection of a private attorney.  37 C.F.R. §2.11.

 

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  

 

 

 

 

 

 

/Howard Smiga/

Examining Attorney

Law Office 102

571-272-9220

Howard.Smiga@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 September 05, 2019 for

U.S. Trademark Application Serial No. 88269944

 

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. 

 

 

/Howard Smiga/

Examining Attorney

Law Office 102

571-272-9220

Howard.Smiga@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 September 05, 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.”