MPEP § 2406.01 — Description in Application Specification (Annotated Rules)

§2406.01 Description in Application Specification

USPTO MPEP version: BlueIron's Update: 2025-12-31

This page consolidates and annotates all enforceable requirements under MPEP § 2406.01, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Description in Application Specification

This section addresses Description in Application Specification. Primary authority: 35 U.S.C. 112, 35 U.S.C. 132, and 37 CFR 1.804(a). Contains: 3 requirements and 6 other statements.

Key Rules

Topic

Deposit Identification in Application

6 rules
StatutoryRequiredAlways
[mpep-2406-01-312c278adb7d6955bc000466]
Description Must Fully Identify Invention
Note:
The application must fully describe the invention, including specific identification and description of any biological deposit made after filing.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
StatutoryInformativeAlways
[mpep-2406-01-f8aac33159111bad25975c35]
Deposit of Immortal B-Cell Line Required
Note:
The application must disclose and claim an immortal B-cell line, along with methods for obtaining and using it.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
StatutoryInformativeAlways
[mpep-2406-01-31bf8951d5e08241c7f6e85e]
Deposit Must Be Described Clearly In Application
Note:
The cell line must be fully described in the application to ensure it can be reduced to practice and accessed by the Office during pendency.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
StatutoryInformativeAlways
[mpep-2406-01-f6818f88384c504833640e30]
Description of Obtaining and Using Cell Line Required in Application
Note:
The application must fully describe the methods for obtaining and using the cell line as filed.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
StatutoryInformativeAlways
[mpep-2406-01-9f5d241cdae85eb8f338492b]
Deposit of Cell Line Required During Pendency and After Grant
Note:
The court ruled that the Office must have access to a cell line sample during the application process and provide public access after grant, as demonstrated by Lundak's procedures.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
StatutoryRequiredAlways
[mpep-2406-01-39001c8dd1ea898d4ac6747d]
Deposit Must Be Clearly Described In Application
Note:
The invention claimed must be fully capable of being reduced to practice and the deposit details must be clearly stated in the application as filed.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit Identification in ApplicationComponents Required for Filing DateReference to Deposit in Specification
Topic

Deposit of Biological Materials

2 rules
StatutoryInformativeAlways
[mpep-2406-01-b19ec847a6d999e8e2944331]
Requirement for Specific Identification of Biological Material
Note:
The application must specifically identify any biological material deposited, which aligns with the description requirement and provides antecedent basis for the deposit.

37 CFR 1.804(a) specifies not only a permissible time frame for making an original deposit, but also specifies that the biological material deposited must be specifically identified in the application for patent as filed. The requirement for a specific identification is consistent with the description requirement of 35 U.S.C. 112 and provides an antecedent basis for the biological material which either has been or will be deposited before the patent is granted.

Jump to MPEP Source · 37 CFR 1.804(a)Deposit of Biological MaterialsDisclosure RequirementsPatent Application Content
StatutoryInformativeAlways
[mpep-2406-01-5508fc97f80f1afc729e1ea2]
Deposit of Cell Line with ATCC Required
Note:
The application must include a deposit of the cell line with the American Type Culture Collection (ATCC) within a week of filing.

The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification “was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).” Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).

Jump to MPEP SourceDeposit of Biological MaterialsDeposit Identification in ApplicationComponents Required for Filing Date
Topic

Time of Making Deposit

1 rules
StatutoryRequiredAlways
[mpep-2406-01-d0ecb27a57ca08bf8b9227fe]
Biological Material Must Be Specifically Identified In Application
Note:
The biological material deposited must be clearly identified in the patent application as filed.

37 CFR 1.804(a) specifies not only a permissible time frame for making an original deposit, but also specifies that the biological material deposited must be specifically identified in the application for patent as filed. The requirement for a specific identification is consistent with the description requirement of 35 U.S.C. 112 and provides an antecedent basis for the biological material which either has been or will be deposited before the patent is granted.

Jump to MPEP Source · 37 CFR 1.804(a)Time of Making DepositDeposit of Biological MaterialsPatent Application Content

Citations

Primary topicCitation
Deposit of Biological Materials
Time of Making Deposit
35 U.S.C. § 112
Deposit Identification in Application
Deposit of Biological Materials
35 U.S.C. § 132
Deposit of Biological Materials
Time of Making Deposit
37 CFR § 1.804(a)
Deposit Identification in Application
Deposit of Biological Materials
Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975)
Deposit Identification in Application
Deposit of Biological Materials
In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985)

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2025-12-31