37 CFR § 1.740 — Formal requirements for application for (MPEP Coverage Index) – BlueIron IP

This page consolidates MPEP guidance interpreting 37 CFR § 1.740, including 83 rules 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.

Summary

The formal requirements for a patent term extension application include submitting a complete and formal written application that adheres to the formal requirements set forth in 37 CFR 1.740.

What this section covers

Defines the mandatory elements of a patent term extension application, including submission as a formal written document.

Key obligations

Mandatory submission of a complete and formal application for extension of patent term in writing.
Provide a complete identification of the approved patent as required by 37 CFR 1.740.
Adhere to the formal requirements set forth in 37 CFR 1.740 for a complete application.

Practice notes

Ensure all required elements are clearly and accurately stated to avoid delays in the application process.
Avoid missing the identification of the approved patent, as it is a critical element that must be included.

Complete Application Requirement for Filing DateMPEP 2754
Sufficient Information for PTE DeterminationMPEP 2754Permitted
Director May Issue Interim Extensions Without RequestMPEP 2755.01Permitted
Patent Owner Notified of Interim ExtensionsMPEP 2755.01
Notice of Interim Extension Is Part of Original PatentMPEP 2755.01
Interim Extensions Cannot Exceed Maximum Eligible PeriodMPEP 2755.01
Application for Patent Term Extension Must Be Submitted by Owner or Agent and Comply with §1.740 RequirementsMPEP 2752Required
Requirements for Patent Term Extension ApplicationMPEP 2753Required
Inquiry and Correspondence Contact Required for Patent Term Extension ApplicationMPEP 2753
Applications and Related Submissions Must Use USPTO Electronic SystemMPEP 2753Required
Notification of Informality for Extension of Patent TermMPEP 2753
Two-Month Time Limit to Correct Informality for Patent Term ExtensionMPEP 2753
Time Extension for Correcting Informality PermittedMPEP 2753Permitted
Requirements for Patent Term Extension ApplicationMPEP 2753Required
Complete Product Description Required for Patent ClaimsMPEP 2753
Complete Federal Statute Identification Required for Regulatory ReviewMPEP 2753
Regulatory Review Under Multiple Federal Statutes Must Be ListedMPEP 2753Recommended
Drug Product or Medical Device Required for PTEMPEP 2753Required
Product Must Be Reviewed as Medical Device or Drug OnlyMPEP 2753
Identify Applicable Federal Statutes for PTE ApplicationMPEP 2753
Approval Date for Drug Products with Controlled Substances Act ControlsMPEP 2753Prohibited
Active Ingredients and Use Indication Required for Drug ProductsMPEP 2753Required
Active Ingredient Approval Status RequiredMPEP 2753Required
Active Ingredient Approval for Food-Producing AnimalsMPEP 2753
Patent Term Extension Submission Period Determined by Covered DateMPEP 2753
Covered Date for PTE ApplicationMPEP 2753
Statement Required for Regulatory Period Determination in PTE ApplicationMPEP 2753Required
Dates for PTE Calculation Must Be ProvidedMPEP 2753Recommended
Testing Phase Begins on Clinical Investigation Start Outside USMPEP 2753Recommended
Provide Reasonable Basis for Claimed DatesMPEP 2753Recommended
Brief Description of Marketing Applicant's Pre-Regulatory Communications RequiredMPEP 2753
Description of Substantive Communications with Regulatory Agency Required for PTE ApplicationMPEP 2753Recommended
Description of Pre-Marketing Communications Required for PTEMPEP 2753
Description of Marketing Activities Not Requiring Due DiligenceMPEP 2753Required
Marketing Applicant Must Be Patent Owner AgentMPEP 2753Required
Marketing Applicant Must Briefly Describe Significant Activities for Patent Term ExtensionMPEP 2753Required
Length of Extension Must Be Stated and CalculatedMPEP 2753
Applicant Must Disclose Material Information to DirectorMPEP 2753
Fee for Extension Application RequiredMPEP 2753
Fee Can Be Paid OnlineMPEP 2753Permitted
Provide Contact Details for Patent Term Extension ApplicationMPEP 2753
Correspondence Address for PTE ApplicationMPEP 2753
Requirement for Change of Address for PTE ApplicationMPEP 2753Recommended
Change of Address for Patent Term Extension Application Does Not Affect Underlying PatentMPEP 2753
Change of Address for Patent Term Extension ApplicationMPEP 2753
Change of Address for Correspondence OnlyMPEP 2753Recommended
Change of Address Must Be Signed by Applicant or PractitionerMPEP 2753
Filing Date Established by Meeting Specific Application RequirementsMPEP 2754
60-Day Filing Period for Complete ApplicationMPEP 2754Required
Application Informalities Must Be CorrectedMPEP 2754Permitted
Time Periods Subject to 1.136 ProvisionsMPEP 2754
Filing Date Established Despite InformalityMPEP 2754
Director Determines Patent Extension Eligibility Based on Application RepresentationsMPEP 2755Permitted
Determination for Patent Extension Eligibility Can Be DelegatedMPEP 2755Permitted
Director Can Request Additional Info Before Patent Extension DeterminationMPEP 2755Permitted
Notification of Patent Extension DeterminationMPEP 2755
Notice Constitutes Final Patent Extension DeterminationMPEP 2755Required
Request for Reconsideration of Final Determination on Patent Extension EligibilityMPEP 2755Permitted
Time Periods for Extension DeterminationMPEP 2755
Request for Interim Patent Term Extension Before ExpirationMPEP 2755.01Recommended

Application for Patent Term Extension Must Be Submitted by Owner or Agent and Comply with §1.740 RequirementsMPEP 2752Required
Requirements for Patent Term Extension ApplicationMPEP 2753Required
Applications and Related Submissions Must Use USPTO Electronic SystemMPEP 2753Required
Requirements for Patent Term Extension ApplicationMPEP 2753Required
Drug Product or Medical Device Required for PTEMPEP 2753Required
Active Ingredients and Use Indication Required for Drug ProductsMPEP 2753Required
Active Ingredient Approval Status RequiredMPEP 2753Required
Application Must Be Submitted Within 60 DaysMPEP 2753Required
Application Must Be Submitted by Next Business Day After HolidayMPEP 2753Required
Three Claims Required for Patent Term ExtensionMPEP 2753Required
Statement Required for Regulatory Period Determination in PTE ApplicationMPEP 2753Required
Description of Marketing Activities Not Requiring Due DiligenceMPEP 2753Required
Marketing Applicant Must Be Patent Owner AgentMPEP 2753Required
Marketing Applicant Must Briefly Describe Significant Activities for Patent Term ExtensionMPEP 2753Required
60-Day Filing Period for Complete ApplicationMPEP 2754Required
Interim Extension for Unapproved ProductMPEP 2754.02Required
Notice Constitutes Final Patent Extension DeterminationMPEP 2755Required
Public Disclosure of Patent Term Extension MaterialsMPEP 2760Required

Definition of Business Day for PTE ApplicationsMPEP 2753
Extension of Patent Term Must Be Filed Within 60 DaysMPEP 2753
Patent Term Extension Expiration Date Must Reflect Adjustments and Terminal DisclaimerMPEP 2753Recommended
Expiration Date Calculated from Filing and AdjustmentsMPEP 2753
PTE Application Must Explain One Product ClaimMPEP 2753
Method of Use Claim Requirement for PTE ApplicationMPEP 2753
Claim for Method of Manufacturing Approved Product RequiredMPEP 2753
Claim Must Read on Approved ProductMPEP 2753Recommended
Claim Must List Corresponding Variables and SubstituentsMPEP 2753
Requirement for Describing 'Means for' Language EquivalentsMPEP 2753Permitted
Claim Chart to Describe Patent Claims on Approved Medical DevicesMPEP 2753Permitted
Patent Interim Extension LimitMPEP 2754.02
Trade Secrets Must Be Submitted According to MPEP §724.02MPEP 2760Recommended
USPTO May Waive Electronic Filing Requirement for Trade Secret SubmissionsMPEP 2760
Identify Trade Secrets By Page, Line, and WordMPEP 2760Recommended
Applicant Determines Trade Secret InformationMPEP 2760
Only Applicant Can Determine Proprietary InfoMPEP 2760
Submission of Proprietary Information for PTEMPEP 2760

MPEP Section	Rules
MPEP § 2752	Application for Patent Term Extension Must Be Submitted by Owner or Agent and Comply with §1.740 RequirementsMPEP 2752Required
MPEP § 2753	Requirements for Patent Term Extension ApplicationMPEP 2753Required Inquiry and Correspondence Contact Required for Patent Term Extension ApplicationMPEP 2753 Applications and Related Submissions Must Use USPTO Electronic SystemMPEP 2753Required Notification of Informality for Extension of Patent TermMPEP 2753 Two-Month Time Limit to Correct Informality for Patent Term ExtensionMPEP 2753 Time Extension for Correcting Informality PermittedMPEP 2753Permitted Requirements for Patent Term Extension ApplicationMPEP 2753Required Complete Product Description Required for Patent ClaimsMPEP 2753 Complete Federal Statute Identification Required for Regulatory ReviewMPEP 2753 Regulatory Review Under Multiple Federal Statutes Must Be ListedMPEP 2753Recommended Drug Product or Medical Device Required for PTEMPEP 2753Required Product Must Be Reviewed as Medical Device or Drug OnlyMPEP 2753 Identify Applicable Federal Statutes for PTE ApplicationMPEP 2753 Approval Date for Drug Products with Controlled Substances Act ControlsMPEP 2753Prohibited Active Ingredients and Use Indication Required for Drug ProductsMPEP 2753Required Active Ingredient Approval Status RequiredMPEP 2753Required Active Ingredient Approval for Food-Producing AnimalsMPEP 2753 Application Must Be Submitted Within 60 DaysMPEP 2753Required Application Must Be Submitted by Next Business Day After HolidayMPEP 2753Required Definition of Business Day for PTE ApplicationsMPEP 2753 Extension of Patent Term Must Be Filed Within 60 DaysMPEP 2753 Patent Term Extension Submission Period Determined by Covered DateMPEP 2753 Covered Date for PTE ApplicationMPEP 2753 Patent Term Extension Expiration Date Must Reflect Adjustments and Terminal DisclaimerMPEP 2753Recommended Expiration Date Calculated from Filing and AdjustmentsMPEP 2753 PTE Application Must Explain One Product ClaimMPEP 2753 Method of Use Claim Requirement for PTE ApplicationMPEP 2753 Claim for Method of Manufacturing Approved Product RequiredMPEP 2753 Three Claims Required for Patent Term ExtensionMPEP 2753Required Claim Must Read on Approved ProductMPEP 2753Recommended Claim Must List Corresponding Variables and SubstituentsMPEP 2753 Requirement for Describing 'Means for' Language EquivalentsMPEP 2753Permitted Claim Chart to Describe Patent Claims on Approved Medical DevicesMPEP 2753Permitted Statement Required for Regulatory Period Determination in PTE ApplicationMPEP 2753Required Dates for PTE Calculation Must Be ProvidedMPEP 2753Recommended Testing Phase Begins on Clinical Investigation Start Outside USMPEP 2753Recommended Provide Reasonable Basis for Claimed DatesMPEP 2753Recommended Brief Description of Marketing Applicant's Pre-Regulatory Communications RequiredMPEP 2753 Description of Substantive Communications with Regulatory Agency Required for PTE ApplicationMPEP 2753Recommended Description of Pre-Marketing Communications Required for PTEMPEP 2753 Description of Marketing Activities Not Requiring Due DiligenceMPEP 2753Required Marketing Applicant Must Be Patent Owner AgentMPEP 2753Required Marketing Applicant Must Briefly Describe Significant Activities for Patent Term ExtensionMPEP 2753Required Length of Extension Must Be Stated and CalculatedMPEP 2753 Applicant Must Disclose Material Information to DirectorMPEP 2753 Fee for Extension Application RequiredMPEP 2753 Fee Can Be Paid OnlineMPEP 2753Permitted Provide Contact Details for Patent Term Extension ApplicationMPEP 2753 Correspondence Address for PTE ApplicationMPEP 2753 Requirement for Change of Address for PTE ApplicationMPEP 2753Recommended Change of Address for Patent Term Extension Application Does Not Affect Underlying PatentMPEP 2753 Change of Address for Patent Term Extension ApplicationMPEP 2753 Change of Address for Correspondence OnlyMPEP 2753Recommended Change of Address Must Be Signed by Applicant or PractitionerMPEP 2753
MPEP § 2754	Complete Application Requirement for Filing DateMPEP 2754 Sufficient Information for PTE DeterminationMPEP 2754Permitted Filing Date Established by Meeting Specific Application RequirementsMPEP 2754 60-Day Filing Period for Complete ApplicationMPEP 2754Required Application Informalities Must Be CorrectedMPEP 2754Permitted Time Periods Subject to 1.136 ProvisionsMPEP 2754 Filing Date Established Despite InformalityMPEP 2754
MPEP § 2754.02	Interim Extension for Unapproved ProductMPEP 2754.02Required Patent Interim Extension LimitMPEP 2754.02
MPEP § 2755	Director Determines Patent Extension Eligibility Based on Application RepresentationsMPEP 2755Permitted Determination for Patent Extension Eligibility Can Be DelegatedMPEP 2755Permitted Director Can Request Additional Info Before Patent Extension DeterminationMPEP 2755Permitted Notification of Patent Extension DeterminationMPEP 2755 Notice Constitutes Final Patent Extension DeterminationMPEP 2755Required Request for Reconsideration of Final Determination on Patent Extension EligibilityMPEP 2755Permitted Time Periods for Extension DeterminationMPEP 2755
MPEP § 2755.01	Director May Issue Interim Extensions Without RequestMPEP 2755.01Permitted Patent Owner Notified of Interim ExtensionsMPEP 2755.01 Notice of Interim Extension Is Part of Original PatentMPEP 2755.01 Interim Extensions Cannot Exceed Maximum Eligible PeriodMPEP 2755.01 Request for Interim Patent Term Extension Before ExpirationMPEP 2755.01Recommended
MPEP § 2760	Public Disclosure of Patent Term Extension MaterialsMPEP 2760Required Trade Secrets Must Be Submitted According to MPEP §724.02MPEP 2760Recommended USPTO May Waive Electronic Filing Requirement for Trade Secret SubmissionsMPEP 2760 Identify Trade Secrets By Page, Line, and WordMPEP 2760Recommended Applicant Determines Trade Secret InformationMPEP 2760 Only Applicant Can Determine Proprietary InfoMPEP 2760 Submission of Proprietary Information for PTEMPEP 2760

Related Provisions

Based on MPEP Last Modified: 10/30/2024 08:50:22

37 CFR § 1.740 — Formal requirements for application for (MPEP Coverage Index) – BlueIron IP

37 CFR § 1.740 Formal requirements for application for

Summary

Official MPEP § 1.740 — Formal requirements for application for

1.740 Formal requirements for application for extension of patent term; correction of informalities.

Verbatim in MPEP

Required Actions

Key Interpretations

Topics

MPEP Coverage

Related Provisions