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 12, 2020

 

 This FINAL Office action is in response to the applicant’s communication filed on 2/26/20.  The requirement for an amended identification of services is withdrawn.

 

 

FINAL SPECIMEN REFUSAL--SECTIONS 1 AND 45

 

 

Applicant was previously refused registration in International Class 40 because the specimen submitted with the application does not show use of the applied-for mark in commerce in connection with the custom manufacturing services identified in the application. Response options for overcoming the refusal were set forth in the prior Office action.  Applicant, however, responded to such refusal by submitting a substitute specimen that does not show proper use of the applied-for mark in commerce in International Class 40 for the reasons previously stated.  Specifically, neither the original specimen submitted with the application, nor the substitute specimen submitted on 2/26/20, show use of the applied-for mark in connection with the manufacturing services identified in International Class 40, but instead show use of the applied-for mark for a pharmaceutical good in International Class 5 beyond the scope of this application.  In this regard, the examiner notes that the substitute specimen states that YESCARTA is in “suspension” form, for “IV infusion”, and is “available at authorized centers.”  It also states that YESCARTA is “a CD19- directed genetically modified autologous T-Cell immunotherapy indicated for the treatment of adult patients..”  Moreover, the substitute specimen specifically indicates that KITE MANUFACTURING is the manufacturer of the YESCARTA pharmaceutical good.

 

See also the attached Internet excerpts from the applicant’s website stating that “YESCARTA is a treatment for your non-Hodgkin lymphoma. It is used when you have failed at least two other kinds of treatment. YESCARTA is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.”

 

Clearly, the totality of evidence of record shows that YESCARTA refers to a pharmaceutical good rather than a manufacturing service.

 

 

In fact, the attached Internet excerpts from the applicant’s website specifically detail warnings and important safety information regarding the use of the YESCARTA pharmaceutical good stating:

 

 

“What is the most important information I should know about YESCARTA?  YESCARTA may cause side effects that are life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:

• Fever (100.4°F/38°C or higher)
• Difficulty breathing
• Chills or shaking chills
• Confusion
• Dizziness or lightheadedness
• Severe nausea, vomiting, or diarrhea
• Fast or irregular heartbeat
• Severe fatigue or weakness

It is important to tell your healthcare provider that you received YESCARTA and to show them your YESCARTA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Before getting YESCARTA, tell your healthcare provider about all your medical problems, including if you have or have had:

• Neurologic problems (such as seizures, stroke, or memory loss)
• Lung or breathing problems
• Heart problems
• Liver problems
• Kidney problems
• A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive YESCARTA?

• Since YESCARTA is made from your own white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
• Your blood cells will be sent to a manufacturing center to make your YESCARTA.
• Before you get YESCARTA, you will get 3 days of chemotherapy to prepare your body.
• When your YESCARTA is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
• You will be monitored where you received your treatment daily for at least 7 days after the infusion.
• You should plan to stay close to the location where you received your treatment for at least 4 weeks after getting YESCARTA. Your healthcare provider will help you with any side effects that may occur.
• You may be hospitalized for side effects and your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
• Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving YESCARTA?

• Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get YESCARTA because the treatment can cause sleepiness, confusion, weakness, temporary memory and coordination problems.
• Do not donate blood, organs, tissues, and cells for transplantation.

What are the possible or reasonably likely side effects of YESCARTA?

The most common side effects of YESCARTA include:

• Fever (100.4°F/38°C or higher)
• Low white blood cells (can occur with a fever)
• Low red blood cells
• Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
• Fast heartbeat
• Confusion
• Difficulty speaking or slurred speech
• Nausea
• Diarrhea

These are not all the possible side effects of YESCARTA. Call your healthcare provider about any side effects that concern you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.”

 

Thus, the refusal to register the applied-for mark in International Class 40 is now maintained and made FINAL because the applicant has failed to provide the required evidence of use of the applied-for mark in commerce in connection with the manufacturing services identified in this class.  Trademark Act Sections 1 and 45, 15 U.S.C. §§1051, 1127; 37 C.F.R. §§2.34(a)(1)(iv), 2.56(a), 2.63(b); TMEP §§904, 904.07, 1301.04(g)(i).

 

 

REQUIREMENT FOR STATEMENT AS TO SIGNIFICANCE OF THE MARK/TRANSLATION STATEMENT ALSO MADE FINAL

 

 

Statement as to significance

 

 

Explain whether the wording “YESCARTA” in the mark has any meaning or significance in the industry in which the services are provided, any meaning or significance as applied to applicant’s services, or if such wording is a term of art within applicant’s industry. 

 

 

Translation statement

 

 

Submit an English translation of all foreign wording in a mark.  If the wording does not have meaning in a foreign language, applicant should so specify.   See below in this regard:

 

 

The format for an English translation is as follows, if relevant herein:  “The English translation of “YESCARTA” is “[indicate translation, if any]”. 

 

The format for when there is no English translation is as follows:  “The wording “YESCARTA” has no meaning in a foreign language. 

 

See 37 C.F.R. §§2.32(a)(9)-(a)(10), 2.61(b); TMEP §§809-809.03, 814. 

 

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.

 

 

Applicant may call or email the assigned trademark examining attorney with questions about this FINAL Office action.  Although an examining attorney cannot provide legal advice, the examining attorney can provide additional explanations about the final refusal and final requirement herein.  See TMEP §§705.02, 709.06. 

 

Note: 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).

 

 

 

 

/Zhaleh Delaney/

Trademark Attorney

Trademark Law Office 116

(571) 272-9153

Zhaleh.Delaney@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 March 12, 2020 for

U.S. Trademark Application Serial No. 88466399

 

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. 

 

 

/Zhaleh Delaney/

Trademark Attorney

Trademark Law Office 116

(571) 272-9153

Zhaleh.Delaney@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 March 12, 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.”