| To: | GW Pharma Ltd (trademark@winthrop.com) |
| Subject: | tmng.notices@uspto.gov |
| Sent: | 2022-06-20 |
| Sent As: | tmng.notices@uspto.gov |
| Attachments: |
U.S. Application Serial No. 79318507
Mark: SATIVEX
| Correspondence Address: Michael T. Olsen Winthrop & Weinstine, P.A. 225 South 6th Street Suite 3500 Minneapolis MN 55402 UNITED STATES |
Applicant: GW Pharma Ltd
Reference/Docket No. N/A
Correspondence Email Address: trademark@winthrop.com
International Registration No. 1594371
Deadline for responding. The USPTO must receive applicant’s response within six months of the “date on which the notification was sent to WIPO (mailing date)” located on the WIPO cover letter, or the U.S. application will be abandoned (see https://www.uspto.gov/trademarks-application-process/abandoned-applications for information on abandonment). To confirm the mailing date, go to the USPTO’s Trademark Status and Document Retrieval (TSDR) database at https://tsdr.uspto.gov/, select “US Serial, Registration, or Reference No.,” enter the U.S. application serial number in the blank text box, and click on “Documents.” The mailing date used to calculate the response deadline is the “Create/Mail Date” of the “IB-1rst Refusal Note.”
Respond to this Office action using the USPTO’s Trademark Electronic Application System (TEAS). A link to the appropriate TEAS response form appears at the end of this Office action.
Discussion of provisional full refusal. This is a provisional full refusal of the request for extension of protection to the United States of the international registration, known in the United States as a U.S. application based on Trademark Act Section 66(a). See 15 U.S.C. §§1141f(a), 1141h(c).
The referenced application 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.
SEARCH OF USPTO DATABASE OF MARKS
The trademark examining attorney searched the USPTO database of registered and pending marks and found no conflicting marks that would bar registration under Trademark Act Section 2(d). 15 U.S.C. §1052(d); TMEP §704.02.
SUMMARY OF ISSUES:
SECTIONS 1 AND 45 PARTIAL REFUSAL – CONTROLLED SUBSTANCES ACT UNLAWFUL USE
THIS PARTIAL REFUSAL APPLIES TO CLASS(ES) 42 & 44 ONLY
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.
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) (stating that “[a] valid application cannot be filed at all for registration of a mark without ‘lawful use in commerce’”); TMEP §907. 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.
The application identifies a connection to cannabis, which encompasses cannabidiol (CBD). See https://jazzpharma.com/medicines/our-medicines/. CBD is a nonpsychoactive constituent of the cannabis plant. Goods containing CBD derived from cannabis that meets the definition of “marijuana” are illegal under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971. In addition, 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). See the Agriculture Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill), which amends the Agricultural Marketing Act of 1946 (AMA). Thus, certain goods and/or services containing or involving hemp, CBD derived from hemp, and/or CBD with less than 0.3 percent tetrahydrocannabinol (THC) that were used in commerce or intend to be used in commerce on or after December 20, 2018 may be lawful under the CSA.
The application is currently refused under the CSA because applicant’s Identification of Goods and/or Services does not identify the source of and/or the THC content of the applicant’s CBD. Thus, the application includes items or activities that are prohibited under the CSA, and as such applicant currently does not have a valid filing basis for any such items or activities.
To the extent applicant’s goods or services involving goods are derived solely from cannabis plants that meet the current statutory definition of “hemp,” and were used or will be used on or after December 20, 2018, such goods and/or services may be lawful if applicant adopts the following response options addressed below.
Response Options Available for Overcoming the CSA Refusal:
Applicant must amend the identification of services to specify that all cannabidiol-containing items and/or hemp derived 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.”
Applicant may adopt one of the following limitations and amend the identification of goods and/or services accordingly:
International Class 042: Scientific and technological services and research and design relating thereto; chemical analysis; chemical research; scientific and technological research and development; research and development on the subject of pharmaceuticals; consultancy relating to pharmaceutical research and development; conducting clinical trials in the field of pharmaceuticals; providing medical and scientific research information in the field of pharmaceuticals and clinical trials; information, advisory and consultancy services in relation to all of the aforesaid services
; any CBD and hemp being featured, provided, or used in the aforementioned services being solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis
International Class 044: Medical services; veterinary services; medical analysis services; medical and veterinary information provided on-line from a computer database or the Internet; horticultural services; provision of horticultural information
; a
ny CBD and hemp being featured, provided, or used
in the aforementioned services being solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis
Applicant is advised that additional amendments to the Identification of Goods and Services are required for clarification purposes as addressed below in this Office Action. The above proposals are required and presented in order to satisfy only the CSA refusal.
SCOPE ADVISORY: Applicant may amend the identification to clarify or limit the goods and/or services, but not to broaden or expand the goods and/or services 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 and/or services may not later be reinserted. See TMEP §1402.07(e).
POTENTIAL UNLAWFUL USE INQUIRY
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 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 to which the proposed mark are applied may be unlawful under the federal Controlled Substances Act (CSA), 21 U.S.C. §§801-971 and the Food, Drug and Cosmetic Act (FDCA). 21 U.S.C. §331(ll); see also 21 U.S.C. §321(ff) (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). Therefore, to the extent the applicant’s goods are derived from cannabis plants that meet the current statutory definition of hemp, the goods may presently be lawful. 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).
This additional information is needed because applicant’s identification of services is written broadly regarding various types of medical services and scientific research services, and makes a connection cannabinol and other cannabinoids. See https://www.jazzpharma.com/medicines/our-medicines/ and https://www.jazzpharma.com/science/gw-cannabinoid-platform/ (showing SATIVEX as being a delta-9 THC CBD product, and explaining applicant's use of cannabinoids generally in medicine). Therefore, further information is required about the nature of the applied-for goods in order to identify whether the applicant has a lawful use in commerce.
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 identified in the application comply with the Controlled Substances Act (CSA) and Food, Drug and Cosmetic Act (FDCA). See 37 C.F.R. §2.69; TMEP §907.
Finally, applicant must provide written responses to the following questions:
Do or will the goods featured in applicant's services include CBD which is derived from, oils, extracts or ingredients from plants other than Cannabis sativa L (also known as hemp, marijuana or cannabis)?
If the answer to Question 4 is “yes”, will or do the goods contain a “milligram” or “mg” content of CBD? And further, does or will the applicant’s packaging or advertising show such a “mg” content of CBD?
If the answer to Question 4 is “yes”, will there be more than a trace amount of CBD in the goods, e.g., more than 50 parts per million (PPM)?
Do or will the goods featured in applicant's services include cannabidiol (CBD)?
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 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.
CLAIM OF PRIOR REGISTRATION
If the marks in the attached registration are owned by applicant, applicant may provide evidence of ownership of the marks by satisfying one of the following:
(1) Record the assignment with the USPTO’s Assignment Recordation Branch (ownership transfer documents such as assignments can be filed online at http://etas.uspto.gov) and promptly notify the trademark examining attorney that the assignment has been duly recorded;
(2) Submit copies of documents evidencing the chain of title; or
(3) Submit the following statement, verified with an affidavit or signed declaration under 37 C.F.R. §2.20: “Applicant is the owner of U.S. Registration No. 4281416.” To provide this statement using the Trademark Electronic Application System (TEAS), use the “Response to Office Action” form; answer “yes” to wizard questions #3 and #9; then, continuing on to the next portion of the form, in the “Additional Statement(s)” section, find “Active Prior Registration(s)” and insert the U.S. registration numbers in the data fields; and follow the instructions within the form for signing. The form must be signed twice; a signature is required both in the “Declaration Signature” section and in the “Response Signature” section.
TMEP §812.01; see 15 U.S.C. §1060; 37 C.F.R. §§2.193(e)(1), 3.25, 3.73(a)-(b); TMEP §502.02(a).
Recording a document with the Assignment Recordation Branch does not constitute a response to an Office action. TMEP §503.01(d).
IDENTIFICATION OF SERVICES
Applicant must clarify the wording throughout in the identification of goods and/or services in International Class(es) 41, 42 & 44 because it is indefinite and too broad. See 37 C.F.R. §2.32(a)(6); TMEP §§1402.01, 1402.03.
The specific issues are set forth below.
Class 41
The identification for “electronic publications” in International Class 41 is indefinite and too broad and must be clarified because the wording does not make clear whether the “publications” are goods or services and if those goods or services are in International Class 9 or 41. See 37 C.F.R. §2.32(a)(6); TMEP §1402.03(e), 1402.11(a)(x).
Applicant must specify whether the electronic publications are provided online and non-downloadable in International Class 41. In addition, applicant must indicate the specific type of publication (e.g., magazines, newsletters, periodicals) and subject matter (e.g., history, biology). See TMEP §§1402.03(e), 1402.11(a)(x).
Class 42
The wording throughout is overly-broad and indefinite, and must be further clarified as to the type or nature of the services being provided in Class 42. For example, the wording "scientific and technological research and development" must clarify the type of research and development services provided, such as new products for others research and development.
Class 44
The wording "medical analysis services" is indefinite, and must be clarified to explain the type of medical analysis services. For example, applicant may clarify that the medical analysis services for diagnosis of diseases like cancer, or that they are generally related to the treatment of persons and/or patients.
The applicant may adopt the following, if accurate:
International Class 041: Educational services, namely, providing [specify, e.g., classes, workshops, educational conferences] in the field of [specify field or subject matter]; provision of training in the field of [specify field or subject matter, e.g., mathematics, science]; instruction services, namely, providing courses of instruction in the field of [specify, e.g., mathematics, science]; educational services, namely, organising and conducting conferences, seminars, educational exhibitions and workshops in the field of [specify field or subject matter]; provision of on-line electronic publications in the nature of [specify publication, e.g., newspapers, e-books, journals] in the field of [specify field or subject matter]; publication of texts, other than publicity texts; publication of scientific texts, other than publicity texts
International Class 042: Scientific and technological services, namely, scientific research and design relating thereto in the field of [specify field or subject matter]; chemical analysis; chemical research; scientific and technological research and development, namely, research and development of new products; research and development on the subject of pharmaceuticals; consultancy relating to pharmaceutical research and development; scientific research in the nature of conducting clinical trials in the field of pharmaceuticals for others; providing medical and scientific research information in the field of pharmaceuticals and clinical trials; information, advisory and consultancy services in relation to all of the aforesaid services
; any CBD and hemp being featured, provided, or used in the aforementioned services being solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis
International Class 044: Medical services; veterinary services; medical analysis services relating to the treatment of persons; medical and veterinary information provided on-line from a computer database or the Internet; horticultural services; provision of horticultural services information
; a
ny CBD and hemp being featured, provided, or used
in the aforementioned services being solely derived from hemp with a delta-9 tetrahydrocannabinol (THC) concentration of not more than 0.3 percent on a dry weight basis
Applicant may amend the identification to clarify or limit the goods and/or services, but not to broaden or expand the goods and/or services 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 and/or services may not later be reinserted. See TMEP §1402.07(e). Additionally, for applications filed under Trademark Act Section 66(a), the scope of the identification for purposes of permissible amendments is limited by the international class assigned by the International Bureau of the World Intellectual Property Organization (International Bureau); and the classification of goods and/or services may not be changed from that assigned by the International Bureau. 37 C.F.R. §2.85(d); TMEP §§1401.03(d), 1904.02(b). Further, in a multiple-class Section 66(a) application, classes may not be added or goods and/or services transferred from one existing class to another. 37 C.F.R. §2.85(d); TMEP §1401.03(d).
Applicant may amend the identification to clarify or limit the goods and/or services, but not to broaden or expand the goods and/or services 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 and/or services 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 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 response to this nonfinal Office action.