MPEP § 2005 — MPEP § 2005
Current through: 2022-07-01

2005-Comparison to Requirements for Information 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2000 

 Section 2005 
 

 
 
 
 
 
 2005 Comparison to Requirements for Information [R-07.2022]

 Under 37
 CFR 1.56 , each individual associated with the filing and prosecution
 of a patent application has a duty to disclose on their own initiative information material
 to patentability under 37
 CFR 1.56 . By contrast, under 37 CFR 1.105 , an examiner or other
 Office employee is authorized to require, from parties identified in 37 CFR 1.56 ,
 information reasonably necessary to examine or treat a matter in an application. The
 provisions of 37 CFR
 1.105 are detailed in MPEP § 704.10 - MPEP § 704.14 et seq. The criteria for requiring information under 37 CFR 1.56 , i.e.,
 materiality to the patentability of claimed subject matter, is substantially higher than
 the criteria for requiring information under 37 CFR 1.105 , i.e., reasonable
 necessity to the examination of the application. See, e.g., Star Fruits S.N.C. v.
 United States, 61393 F.3d 1277, 1282, 73 USPQ2d 1409, 1413 (Fed. Cir. 2005)
 (“We think it clear that ‘such information as may be reasonably necessary to properly
 examine or treat the matter,’ 37 C.F.R. 1.105(a)(1), contemplates information relevant to
 examination either procedurally or substantively. It includes a zone of information beyond
 that defined by section 1.56 as material to patentability, and beyond that which is
 directly useful to support a rejection or conclusively decide the issue of
 patentability.”). See also Hyatt v. USPTO, 797 F.3d 1374, 116 USPQ2d
 1331 (Fed. Cir. 2015). Information required by the examiner pursuant to 37 CFR 1.105 would
 not necessarily be considered material to patentability in itself, but would be necessary
 to obtain a complete record from which a determination of patentability will be made.
 

 Therefore, when an examiner has a reasonable basis to
 conclude that an individual identified under 37 CFR 1.56(c) or any assignee has
 information that would aid in the examination of the application or treatment of some
 matter, the examiner may require additional information. This requirement could include
 statements made or information submitted to other Government agencies such as the FDA. For
 example, when examining a claim directed to a process of manufacturing a particular drug
 product that was effectively filed more than one year after FDA approval of the drug
 product, an examiner may appropriately require an applicant to submit to the USPTO
 information submitted to the FDA (e.g., in a New Drug Application or Biologics License
 Application) on how the drug product was manufactured. 
 

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 2000-Duty of Disclosure 
 2000.01-Introduction 

 
 

 2001-Duty of Disclosure, Candor, and Good Faith 
 2001.01-Who Has Duty To Disclose 

 2001.02-[Reserved] 

 2001.03-To Whom Duty of Disclosure Is Owed 

 2001.04-Information Under 37 CFR 1.56(a) 

 2001.05-Materiality Under 37 CFR 1.56(b) 

 2001.06-Sources of Information under 37 CFR 1.56 
 2001.06(a)-Prior Art Cited in Related Foreign Applications 

 2001.06(b)-Information Relating to or From Copending United States Patent Applications 

 2001.06(c)-Information From Related Litigation and/or Trial Proceedings 

 2001.06(d)-Information Relating to Claims Copied From a Patent 

 2001.06(e)-Information Relating to Regulatory Review 

 
 

 
 

 2002-Disclosure — By Whom and How Made 
 2002.01-By Whom Made 

 2002.02-Must be in Writing 

 
 

 2003-Disclosure __ When Made 
 2003.01-Disclosure After Patent Is Granted 

 
 

 2004-Aids to Compliance With Duty of Disclosure 

 2005-Comparison to Requirements for Information 

 2006‑2009-[Reserved] 

 2010-Office Handling of Duty of Disclosure/Inequitable Conduct Issues 

 2011-Correction of Errors in Application 

 2012-Reissue Applications Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 
 2012.01-Collateral Estoppel 

 
 

 2013-Protests Involving Issues of Fraud, Inequitable Conduct, and/or Violation of Duty of Disclosure 

 2014-Duty of Disclosure in Reexamination Proceedings and Supplemental Examination 

 2015-Duties of Disclosure and Reasonable Inquiry Arise in Dealings With Other Government Agencies 

 2016-Fraud, Inequitable Conduct, or Violation of Duty of Disclosure Affects All Claims 

 2017‑2022-[Reserved] 

 

 

 
 

 
 
 

 
 

 

 
 
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 03/09/2026 20:49:31