Can an examiner require information submitted to other government agencies?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-29 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. 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 examiner might require the applicant to submit information provided to the FDA about the manufacturing process. This could include information from: New Drug Applications (NDAs) Biologics License Applications (BLAs) Such requirements are based on the examiner’s authority under 37 CFR 1.105 to request information reasonably necessary for examination. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Examiner Can Require Information Under 37 CFR 1.105 MPEP 2005 Examiner Can Require Drug Product Manufacturing Details MPEP 2005 Permitted Duty of Disclosure Materiality Revised Based on Therasense MPEP 2000 Duty of Disclosure to Adopt But-For Materiality Standard MPEP 2000 Guidance on Compliance with Duty of Disclosure Regardless of Materiality Standard MPEP 2000 Information Required for Examination Not Necessarily Material to Patentability MPEP 2005 Required AIA Amends Duty to Disclose Errors Without Deceptive Intent MPEP 2000 Requirement for Examiner to Obtain Reasonably Necessary Information MPEP 2005 Duty to Disclose Material Information to USPTO MPEP 2000 Individuals Must Disclose Material Information MPEP 2000 Other Related FAQs 5 FAQs Collapse What is the difference between the duty to disclose under 37 CFR 1.56 and the requirements for information under 37 CFR 1.105? What type of information can an ex...