| Under the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless it displays a valid OMB control number. PTO Form 1957 (Rev 10/2011) |
| OMB No. 0651-0050 (Exp 09/20/2020) |
| Input Field |
Entered |
|---|---|
| SERIAL NUMBER | 87901553 |
| LAW OFFICE ASSIGNED | LAW OFFICE 103 |
| MARK SECTION | |
| MARK | http://uspto.report/TM/87901553/mark.png |
| LITERAL ELEMENT | ADSTILADRIN |
| STANDARD CHARACTERS | YES |
| USPTO-GENERATED IMAGE | YES |
| MARK STATEMENT | The mark consists of standard characters, without claim to any particular font style, size or color. |
| ARGUMENT(S) | |
|
Registration is refused because the Examiner alleges that the specimen "appears to consist of a digitally altered image or a mock-up." Wrong. The specimen previously submitted is, as Applicant has repeatedly said before - a photograph. Specifically, a photograph of vials containing nadofaragene firadenovec, an investigational new drug for cancer. The Examiner argues, "An image of a product or its packaging that has been digitally created or otherwise altered to include the mark does not show actual use of the mark in commerce." That is correct but irrelevant. The specimen previously submitted was not digitally created. It has not been altered. It is not a mock up. It is, as I have repeatedly said before, a photograph of vials containing Applicant's product. The Examiner correctly notes, "Applicant must show the mark on applicant’s own goods or packaging as it is seen by the purchasing
public, with goods that have actually been sold or transported in commerce." The previously submitted specimen shows this. The Examiner requests answers to the following questions and requests for documentation to satisfy this request for information:
(1) How are applicant’s goods sold? Specify the
retail, wholesale, or other sales environment in which the goods are sold. Answer: Adstiladrin(TM) brand nadofaragene firadenovec is an investigational new drug. It is not sold. It is distributed
gratis. Further, it is not distributed in a retail sales environment. It is shipped to hospital pharmacies at
major teaching hospitals and cancer research centers. It is being tested as an investigational new drug, to support the Food & Drug Administration review and approval process. This
use is in the ordinary course of trade in the pharmaceutical industry. It thus supports registration. See TMEP 901.02.
(2) Please provide copies of invoices, bills of sale, or other documentation of sales of the goods. Answer: As stated above, this product is an
investigational new drug. As such, it cannot legally be sold.
(3) Was the specimen created for submission with this application? Answer: No. The Applicant maintains an inventory of this product to supply its two on-going
clinical trials.
(4) Does the specimen show applicant’s product as it is currently being sold to consumers?
Answer: The specimen shows applicant's product as it is currently being distributed to hospital pharmacies. (5) How do applicant’s goods appear in the actual sales environment? If sold in
stores, provide photos showing the goods for sale in the stores. If sold online, identify the websites and provide copies of the webpages showing the goods for
sale. And if sold in another type of sales environment, provide photos and/or documentation showing the goods for sale in that environment. Answer: See response to Question #6
below.
(6) If the information in question (5) about how the goods appear in the actual sales
environment is not available to applicant, then please describe how applicant’s goods are transported for sale and provide photos and other documentation showing how applicant’s mark appears on the
goods and/or its packaging when the goods are being transported for sale. Answer: Vials
of nadofaragene firadenovec are packaged in a carton together with vials of diluent and other ingredients
which the hospital pharmacist uses to reconstitute a finished dosage form for administration to a patient. I enclose a photograph of an example of such a carton. Cartons are transported from the warehouse / distribution center to the hospital pharmacy
frozen in dry ice to preserve the product. When delivered to the hospital pharmacy, the pharmacy stores the carton in a -70 freezer, again to preserve the product. When a patient is ready
for treatment, the pharmacist opens the carton and mixes the contents of the various vials to prepare the finished dosage form.
Conclusion: As I've said before, the
previously-submitted photograph shows actual vials of Applicant's product. That is a photograph. It is not a digital mock-up. It is not an altered
photograph.
|
|
| EVIDENCE SECTION | |
| EVIDENCE FILE NAME(S) | |
| ORIGINAL PDF FILE | evi_6911223098-20190701133754290093_._outer_box_-_opened.pdf |
| CONVERTED PDF FILE(S) (1 page) |
\\TICRS\EXPORT17\IMAGEOUT17\879\015\87901553\xml17\ROA0002.JPG |
| DESCRIPTION OF EVIDENCE FILE | A photograph (not merely a digital mock up, nor an altered image) of a sample of the outer carton used to package and ship vials of product. |
| SIGNATURE SECTION | |
| RESPONSE SIGNATURE | /mark pohl/ |
| SIGNATORY'S NAME | J. Mark Pohl |
| SIGNATORY'S POSITION | Attorney of record, Pennsylvania bar member |
| SIGNATORY'S PHONE NUMBER | (973) 984-6159 |
| DATE SIGNED | 07/01/2019 |
| AUTHORIZED SIGNATORY | YES |
| FILING INFORMATION SECTION | |
| SUBMIT DATE | Mon Jul 01 15:18:35 EDT 2019 |
| TEAS STAMP | USPTO/ROA-XX.XXX.XXX.XX-2 0190701151835986521-87901 553-6209528fca4dadd512c9d 3d14f821c01a3b57f12554c85 b538f3d12eb72444fd-N/A-N/ A-20190701133754290093 |
| Under the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless it displays a valid OMB control number. PTO Form 1957 (Rev 10/2011) |
| OMB No. 0651-0050 (Exp 09/20/2020) |
Registration is refused because the Examiner alleges that the specimen "appears to consist of a digitally altered image or a mock-up." Wrong. The specimen previously submitted is, as Applicant has repeatedly said before - a photograph. Specifically, a photograph of vials containing nadofaragene firadenovec, an investigational new drug for cancer.
The Examiner argues, "An image of a product or its packaging that has been digitally created or otherwise altered to include the mark does not show actual use of the mark in commerce." That is correct but irrelevant. The specimen previously submitted was not digitally created. It has not been altered. It is not a mock up. It is, as I have repeatedly said before, a photograph of vials containing Applicant's product.
The Examiner correctly notes, "Applicant must show the mark on applicant’s own goods or packaging as it is seen by the purchasing
public, with goods that have actually been sold or transported in commerce." The previously submitted specimen shows this.
