FAQs Patent Questions

Question:Applicants must submit amendments to drawings as replacement or new drawings together with explanations of the changes

Answer:
Applicant must submit any amendments to drawings as replacement or new drawings accompanied by explanations of the changes in either the drawing amendment section or remarks section of the amendment paper. Any replacement sheets of drawings must be labeled as "Replacement Sheet" and any new sheets of drawings must be labeled as "New Sheet" in the header.

Question:What is FDA’s role in the Patent Term Restoration Program?

Answer:
FDA’s primary responsibility is to assist the Patent Trademark Office (PTO) in determining a product’s eligibility for patent term restoration and to provide information to PTO regarding a product’s regulatory review period.

Question:Is there any danger that the USPTO will give others information contained in my application while it is pending?

Answer:
Most patent applications filed on or after November 29, 2000, will be published 18 months after the filing date of the application, or any earlier filing date relied upon under Title 35, United States Code. Otherwise, all patent applications are maintained in the strictest confidence until the patent is issued or the application is published. After the application has been published, however, a member of the public may request a copy of the application file.

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