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.

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.

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.

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.

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.

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.