Can an examiner require information submitted to other government agencies?
Yes, an examiner can require information submitted to other government agencies under certain circumstances. The MPEP states: “This requirement could include statements made or information submitted to other Government agencies such as the FDA.” For example, when examining a claim related to a drug manufacturing process filed more than a year after FDA approval, an…
Read MoreHow does the USPTO handle enablement issues in drug-related patent applications?
For drug-related patent applications, the USPTO has specific guidelines addressing enablement issues. The MPEP 2164.06(a) directs examiners and applicants to additional resources: See MPEP § 2107 – § 2107.03 for a discussion of the utility requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, in drug cases. This reference to MPEP §…
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