Patent Law FAQ
This FAQ answers all your questions about patent law, patent procedure, and the patent examination process.
MPEP 2400 – Biotechnology (15)
A Sequence Identifier (SEQ ID NO) is a unique number assigned to each disclosed nucleic acid and/or amino acid sequence in a patent application. According to MPEP 2422.01:
“37 CFR 1.821(d) and 37 CFR 1.823(a)(5) require that each disclosed nucleic acid and/or amino acid sequence in the application appear separately in the “Sequence Listing”, with each sequence further being assigned a sequence identifier, referred to as “SEQ ID NO:” or the like.“
Key points about Sequence Identifiers:
- They must begin with 1 and increase sequentially by integers.
- Each sequence must have a different number for identification.
- Sequences should be presented in numerical order in the “Sequence Listing” where practical.
- When discussing a sequence in the description or claims, a reference to its SEQ ID NO is required at all occurrences.
- SEQ ID NOs can be used to discuss or claim parts of a sequence (e.g., “residues 14 to 243 of SEQ ID NO:23”).
The use of SEQ ID NOs provides a shorthand way for applicants to discuss and claim their inventions without restricting how an invention can be claimed.
To learn more:
Sequence identifiers (SEQ ID NOs) are crucial in patent applications containing nucleotide and/or amino acid sequences. According to MPEP 2421.02:
- Each disclosed nucleotide and/or amino acid sequence must be assigned a unique SEQ ID NO.
- SEQ ID NOs must be used to identify sequences in the specification, claims, and drawings.
- The SEQ ID NO should be placed adjacent to the sequence or used in a table correlating sequence names with their corresponding SEQ ID NOs.
The MPEP states: “The rules require that the sequence identifiers must be used in all instances where the sequences are disclosed in a patent application.” This ensures clear and consistent referencing of sequences throughout the application.
To learn more:
The case of Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990) is mentioned in MPEP 2410.01 in the context of biological material deposits. This case is significant because it reinforces the requirement that all restrictions on access to deposited biological material must be removed upon patent grant, with only the specific exception allowed under 37 CFR 1.808(b).
The MPEP cites this case to emphasize that compliance with the Budapest Treaty alone is not sufficient to meet all U.S. requirements for biological deposits. Specifically, the MPEP states: Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
To learn more:
For patent applications filed on or after January 1, 2022, the USPTO has specific procedures for handling defective sequence listings. According to MPEP 2422.07:
“Applications filed on or after January 1, 2022, that are otherwise complete, but that contain defective sequence listings, will be accepted and the defective sequence listing will be treated in accordance with 37 CFR 1.52(e)(8).”
This means:
- The application will be accepted for filing.
- The applicant will be notified of the defective sequence listing.
- The applicant will be given a period of time to correct the defective sequence listing.
- If the defect is not corrected within the specified time, the application may be held abandoned.
It’s important to note that this procedure differs from that for applications filed before January 1, 2022, which were subject to different rules regarding sequence listing defects.
To learn more:
Under the new Sequence Rules, patent applicants must submit sequence listings in a specific format. MPEP 2412.01 states that “an applicant is required to submit sequence data… in eXtensible Markup Language (XML) format.”
This XML file must conform to the requirements specified in 37 CFR 1.831 – 1.834, which in turn reference particular paragraphs of WIPO Standard ST.26. The use of XML format ensures standardization and machine-readability of sequence data across different patent offices worldwide.
To learn more:
A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a).
The MPEP states: 37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823.
To learn more:
According to MPEP 2412.05(a), intentionally skipped sequences must be included in the “Sequence Listing XML” and represented as follows:
- Use the element SequenceData and its attribute sequenceIDNumber, providing the sequence identifier of the skipped sequence as the value.
- Include the elements INSDSeq_length, INSDSeq_moltype, and INSDSeq_division, but with no value provided.
- Do not include the element INSDSeq_feature-table.
- Use the element INSDSeq_sequence with the string “000” as the value.
The MPEP states: “Where no sequence is present for a sequence identifier, i.e. an intentionally skipped sequence, ‘000’ must be used in place of a sequence.” This ensures that the total number of sequences in the listing matches the total number of sequence identifiers, maintaining consistency and completeness in the documentation.
To learn more:
The element in a Sequence Listing XML is used to describe features of the sequence. Here’s how it’s structured and used:
- It contains one or more elements.
- Each element describes a specific feature of the sequence.
- Features can include biological significance, such as coding regions or mutation sites.
The MPEP 2413.01 states: “The contains one or more elements.” This table allows applicants to provide detailed information about specific regions or characteristics of the sequence, which is crucial for understanding its biological function and patentability.
To learn more:
What are the requirements for INSDSeq_length in a Sequence Listing XML?
According to MPEP 2413, the INSDSeq_length element in a Sequence Listing XML has specific requirements:
- It must be a positive integer
- It represents the number of residues in the sequence
- For nucleotide sequences, it includes both nucleotides and nucleotide analogs
- For amino acid sequences, it includes amino acids, modified amino acids, and unknown amino acids
MPEP 2413 states: “The length of the sequence must be indicated by a positive integer expressing the number of residues.”
This element is crucial for accurately representing the size of each sequence in the Sequence Listing XML file.
To learn more:
The element in a Sequence Listing XML serves a specific purpose in identifying the type of molecule being described. Here’s how it functions:
- It specifies whether the sequence is DNA, RNA, or protein.
- This information is crucial for proper interpretation of the sequence data.
- It helps in determining the appropriate analysis methods and tools to be used.
The MPEP 2413.01 mentions the as one of the elements within the container. By clearly indicating the molecule type, this element ensures that patent examiners and other readers can correctly understand and evaluate the sequence information provided in the application.
To learn more:
The element in a Sequence Listing XML serves a specific purpose:
- It is used to provide additional sequence identifiers for a given sequence.
- This element can contain one or more sub-elements.
- Each sub-element represents an alternative identifier for the sequence.
According to MPEP 2413.01, “The contains one or more elements identifying alternative sequences.” This allows for flexibility in referencing sequences using different identification systems or nomenclatures.
To learn more:
The element in a Sequence Listing XML contains crucial information about the actual sequence. Here’s what it includes:
- The raw sequence data itself.
- It represents the order of nucleotides (for DNA/RNA) or amino acids (for proteins).
- The sequence is presented without spaces or numbers.
According to MPEP 2413.01, “The contains the raw sequence data.” This element is essential as it provides the core information about the biological sequence being disclosed in the patent application.
To learn more:
When submitting a “Sequence Listing XML” in response to a notice from the United States International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), applicants are required to pay a late furnishing fee. According to MPEP 2414.05:
“In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required.”
This fee is in addition to the submission of the “Sequence Listing XML” and a statement that the information does not go beyond the original disclosure. The specific amount of the fee can be found in 37 CFR 1.445(a)(5) and is subject to change, so applicants should consult the current fee schedule on the USPTO website.
To learn more:
When submitting a “Sequence Listing XML” on read-only optical discs, proper labeling and packaging are crucial. According to MPEP 2413.03, follow these guidelines:
- Marking: All read-only optical discs, fees, and accompanying papers should be marked “Mail Stop SEQUENCE.”
- Hand delivery: For hand delivery to the Customer Service Window, place the disc in a protective mailer labeled with at least the application number (if available).
- Labeling requirements: Adhere to the labeling requirements of 37 CFR 1.52(e) and 1.834(b)(2).
- Packaging: Use staples and clips carefully to attach the mailer to the submitted papers without contacting or compressing the media.
- Multiple discs: If a compressed XML file doesn’t fit on a single disc, it may be split into multiple parts, labeled in compliance with § 1.52(e)(5)(vi).
The MPEP also states: “In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.”
By following these guidelines, you ensure proper handling and processing of your “Sequence Listing XML” submission.
To learn more:
Yes, applicants need to specify the term of deposit even if it’s made under the Budapest Treaty. The MPEP clearly states:
Unless applicant indicates that the deposit has been made under the Budapest Treaty, applicant must indicate the term for which the deposit has been made.
This means that if the deposit is not explicitly stated to be under the Budapest Treaty, the applicant must provide information about the term of deposit. Even for Budapest Treaty deposits, it’s advisable to clearly state the term to avoid any potential issues or misunderstandings during the examination process.
To learn more:
MPEP 2408 – Term Of Deposit (1)
Yes, applicants need to specify the term of deposit even if it’s made under the Budapest Treaty. The MPEP clearly states:
Unless applicant indicates that the deposit has been made under the Budapest Treaty, applicant must indicate the term for which the deposit has been made.
This means that if the deposit is not explicitly stated to be under the Budapest Treaty, the applicant must provide information about the term of deposit. Even for Budapest Treaty deposits, it’s advisable to clearly state the term to avoid any potential issues or misunderstandings during the examination process.
To learn more:
MPEP 2410.01 – Conditions Of Deposit (1)
The case of Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990) is mentioned in MPEP 2410.01 in the context of biological material deposits. This case is significant because it reinforces the requirement that all restrictions on access to deposited biological material must be removed upon patent grant, with only the specific exception allowed under 37 CFR 1.808(b).
The MPEP cites this case to emphasize that compliance with the Budapest Treaty alone is not sufficient to meet all U.S. requirements for biological deposits. Specifically, the MPEP states: Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
To learn more:
MPEP 2412.01 – Overview Of The Sequence Rules (1)
Under the new Sequence Rules, patent applicants must submit sequence listings in a specific format. MPEP 2412.01 states that “an applicant is required to submit sequence data… in eXtensible Markup Language (XML) format.”
This XML file must conform to the requirements specified in 37 CFR 1.831 – 1.834, which in turn reference particular paragraphs of WIPO Standard ST.26. The use of XML format ensures standardization and machine-readability of sequence data across different patent offices worldwide.
To learn more:
MPEP 2412.05(A) – Use Of Sequentially Numbered Sequence Identifiers In The "Sequence Listing Xml" (1)
According to MPEP 2412.05(a), intentionally skipped sequences must be included in the “Sequence Listing XML” and represented as follows:
- Use the element SequenceData and its attribute sequenceIDNumber, providing the sequence identifier of the skipped sequence as the value.
- Include the elements INSDSeq_length, INSDSeq_moltype, and INSDSeq_division, but with no value provided.
- Do not include the element INSDSeq_feature-table.
- Use the element INSDSeq_sequence with the string “000” as the value.
The MPEP states: “Where no sequence is present for a sequence identifier, i.e. an intentionally skipped sequence, ‘000’ must be used in place of a sequence.” This ensures that the total number of sequences in the listing matches the total number of sequence identifiers, maintaining consistency and completeness in the documentation.
To learn more:
MPEP 2413 – Content Of "Sequence Listing Xml" And Form And Format Of The "Sequence Listing Xml" File (1)
What are the requirements for INSDSeq_length in a Sequence Listing XML?
According to MPEP 2413, the INSDSeq_length element in a Sequence Listing XML has specific requirements:
- It must be a positive integer
- It represents the number of residues in the sequence
- For nucleotide sequences, it includes both nucleotides and nucleotide analogs
- For amino acid sequences, it includes amino acids, modified amino acids, and unknown amino acids
MPEP 2413 states: “The length of the sequence must be indicated by a positive integer expressing the number of residues.”
This element is crucial for accurately representing the size of each sequence in the Sequence Listing XML file.
To learn more:
MPEP 2413.01 – Parts Of The "Sequence Listing Xml" (4)
The element in a Sequence Listing XML is used to describe features of the sequence. Here’s how it’s structured and used:
- It contains one or more elements.
- Each element describes a specific feature of the sequence.
- Features can include biological significance, such as coding regions or mutation sites.
The MPEP 2413.01 states: “The contains one or more elements.” This table allows applicants to provide detailed information about specific regions or characteristics of the sequence, which is crucial for understanding its biological function and patentability.
To learn more:
The element in a Sequence Listing XML serves a specific purpose in identifying the type of molecule being described. Here’s how it functions:
- It specifies whether the sequence is DNA, RNA, or protein.
- This information is crucial for proper interpretation of the sequence data.
- It helps in determining the appropriate analysis methods and tools to be used.
The MPEP 2413.01 mentions the as one of the elements within the container. By clearly indicating the molecule type, this element ensures that patent examiners and other readers can correctly understand and evaluate the sequence information provided in the application.
To learn more:
The element in a Sequence Listing XML serves a specific purpose:
- It is used to provide additional sequence identifiers for a given sequence.
- This element can contain one or more sub-elements.
- Each sub-element represents an alternative identifier for the sequence.
According to MPEP 2413.01, “The contains one or more elements identifying alternative sequences.” This allows for flexibility in referencing sequences using different identification systems or nomenclatures.
To learn more:
The element in a Sequence Listing XML contains crucial information about the actual sequence. Here’s what it includes:
- The raw sequence data itself.
- It represents the order of nucleotides (for DNA/RNA) or amino acids (for proteins).
- The sequence is presented without spaces or numbers.
According to MPEP 2413.01, “The contains the raw sequence data.” This element is essential as it provides the core information about the biological sequence being disclosed in the patent application.
To learn more:
MPEP 2413.03 – How To Submit The "Sequence Listing Xml" (1)
When submitting a “Sequence Listing XML” on read-only optical discs, proper labeling and packaging are crucial. According to MPEP 2413.03, follow these guidelines:
- Marking: All read-only optical discs, fees, and accompanying papers should be marked “Mail Stop SEQUENCE.”
- Hand delivery: For hand delivery to the Customer Service Window, place the disc in a protective mailer labeled with at least the application number (if available).
- Labeling requirements: Adhere to the labeling requirements of 37 CFR 1.52(e) and 1.834(b)(2).
- Packaging: Use staples and clips carefully to attach the mailer to the submitted papers without contacting or compressing the media.
- Multiple discs: If a compressed XML file doesn’t fit on a single disc, it may be split into multiple parts, labeled in compliance with § 1.52(e)(5)(vi).
The MPEP also states: “In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.”
By following these guidelines, you ensure proper handling and processing of your “Sequence Listing XML” submission.
To learn more:
MPEP 2421.01 – Definition Of "Sequence Listing" And Computer Readable Form (Crf) (1)
A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a).
The MPEP states: 37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823.
To learn more:
MPEP 2421.02 – Summary Of The Requirements Of The Sequence Rules (1)
Sequence identifiers (SEQ ID NOs) are crucial in patent applications containing nucleotide and/or amino acid sequences. According to MPEP 2421.02:
- Each disclosed nucleotide and/or amino acid sequence must be assigned a unique SEQ ID NO.
- SEQ ID NOs must be used to identify sequences in the specification, claims, and drawings.
- The SEQ ID NO should be placed adjacent to the sequence or used in a table correlating sequence names with their corresponding SEQ ID NOs.
The MPEP states: “The rules require that the sequence identifiers must be used in all instances where the sequences are disclosed in a patent application.” This ensures clear and consistent referencing of sequences throughout the application.
To learn more:
MPEP 2422.01 – Nucleotide And/Or Amino Acids Disclosures Requiring A "Sequence Listing" (1)
A Sequence Identifier (SEQ ID NO) is a unique number assigned to each disclosed nucleic acid and/or amino acid sequence in a patent application. According to MPEP 2422.01:
“37 CFR 1.821(d) and 37 CFR 1.823(a)(5) require that each disclosed nucleic acid and/or amino acid sequence in the application appear separately in the “Sequence Listing”, with each sequence further being assigned a sequence identifier, referred to as “SEQ ID NO:” or the like.“
Key points about Sequence Identifiers:
- They must begin with 1 and increase sequentially by integers.
- Each sequence must have a different number for identification.
- Sequences should be presented in numerical order in the “Sequence Listing” where practical.
- When discussing a sequence in the description or claims, a reference to its SEQ ID NO is required at all occurrences.
- SEQ ID NOs can be used to discuss or claim parts of a sequence (e.g., “residues 14 to 243 of SEQ ID NO:23”).
The use of SEQ ID NOs provides a shorthand way for applicants to discuss and claim their inventions without restricting how an invention can be claimed.
To learn more:
MPEP 2422.07 – Requirements For Compliance And Consequences Of Non – Compliance (1)
For patent applications filed on or after January 1, 2022, the USPTO has specific procedures for handling defective sequence listings. According to MPEP 2422.07:
“Applications filed on or after January 1, 2022, that are otherwise complete, but that contain defective sequence listings, will be accepted and the defective sequence listing will be treated in accordance with 37 CFR 1.52(e)(8).”
This means:
- The application will be accepted for filing.
- The applicant will be notified of the defective sequence listing.
- The applicant will be given a period of time to correct the defective sequence listing.
- If the defect is not corrected within the specified time, the application may be held abandoned.
It’s important to note that this procedure differs from that for applications filed before January 1, 2022, which were subject to different rules regarding sequence listing defects.
To learn more:
Patent Law (15)
A Sequence Identifier (SEQ ID NO) is a unique number assigned to each disclosed nucleic acid and/or amino acid sequence in a patent application. According to MPEP 2422.01:
“37 CFR 1.821(d) and 37 CFR 1.823(a)(5) require that each disclosed nucleic acid and/or amino acid sequence in the application appear separately in the “Sequence Listing”, with each sequence further being assigned a sequence identifier, referred to as “SEQ ID NO:” or the like.“
Key points about Sequence Identifiers:
- They must begin with 1 and increase sequentially by integers.
- Each sequence must have a different number for identification.
- Sequences should be presented in numerical order in the “Sequence Listing” where practical.
- When discussing a sequence in the description or claims, a reference to its SEQ ID NO is required at all occurrences.
- SEQ ID NOs can be used to discuss or claim parts of a sequence (e.g., “residues 14 to 243 of SEQ ID NO:23”).
The use of SEQ ID NOs provides a shorthand way for applicants to discuss and claim their inventions without restricting how an invention can be claimed.
To learn more:
Sequence identifiers (SEQ ID NOs) are crucial in patent applications containing nucleotide and/or amino acid sequences. According to MPEP 2421.02:
- Each disclosed nucleotide and/or amino acid sequence must be assigned a unique SEQ ID NO.
- SEQ ID NOs must be used to identify sequences in the specification, claims, and drawings.
- The SEQ ID NO should be placed adjacent to the sequence or used in a table correlating sequence names with their corresponding SEQ ID NOs.
The MPEP states: “The rules require that the sequence identifiers must be used in all instances where the sequences are disclosed in a patent application.” This ensures clear and consistent referencing of sequences throughout the application.
To learn more:
The case of Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990) is mentioned in MPEP 2410.01 in the context of biological material deposits. This case is significant because it reinforces the requirement that all restrictions on access to deposited biological material must be removed upon patent grant, with only the specific exception allowed under 37 CFR 1.808(b).
The MPEP cites this case to emphasize that compliance with the Budapest Treaty alone is not sufficient to meet all U.S. requirements for biological deposits. Specifically, the MPEP states: Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
To learn more:
For patent applications filed on or after January 1, 2022, the USPTO has specific procedures for handling defective sequence listings. According to MPEP 2422.07:
“Applications filed on or after January 1, 2022, that are otherwise complete, but that contain defective sequence listings, will be accepted and the defective sequence listing will be treated in accordance with 37 CFR 1.52(e)(8).”
This means:
- The application will be accepted for filing.
- The applicant will be notified of the defective sequence listing.
- The applicant will be given a period of time to correct the defective sequence listing.
- If the defect is not corrected within the specified time, the application may be held abandoned.
It’s important to note that this procedure differs from that for applications filed before January 1, 2022, which were subject to different rules regarding sequence listing defects.
To learn more:
Under the new Sequence Rules, patent applicants must submit sequence listings in a specific format. MPEP 2412.01 states that “an applicant is required to submit sequence data… in eXtensible Markup Language (XML) format.”
This XML file must conform to the requirements specified in 37 CFR 1.831 – 1.834, which in turn reference particular paragraphs of WIPO Standard ST.26. The use of XML format ensures standardization and machine-readability of sequence data across different patent offices worldwide.
To learn more:
A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a).
The MPEP states: 37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823.
To learn more:
According to MPEP 2412.05(a), intentionally skipped sequences must be included in the “Sequence Listing XML” and represented as follows:
- Use the element SequenceData and its attribute sequenceIDNumber, providing the sequence identifier of the skipped sequence as the value.
- Include the elements INSDSeq_length, INSDSeq_moltype, and INSDSeq_division, but with no value provided.
- Do not include the element INSDSeq_feature-table.
- Use the element INSDSeq_sequence with the string “000” as the value.
The MPEP states: “Where no sequence is present for a sequence identifier, i.e. an intentionally skipped sequence, ‘000’ must be used in place of a sequence.” This ensures that the total number of sequences in the listing matches the total number of sequence identifiers, maintaining consistency and completeness in the documentation.
To learn more:
The element in a Sequence Listing XML is used to describe features of the sequence. Here’s how it’s structured and used:
- It contains one or more elements.
- Each element describes a specific feature of the sequence.
- Features can include biological significance, such as coding regions or mutation sites.
The MPEP 2413.01 states: “The contains one or more elements.” This table allows applicants to provide detailed information about specific regions or characteristics of the sequence, which is crucial for understanding its biological function and patentability.
To learn more:
What are the requirements for INSDSeq_length in a Sequence Listing XML?
According to MPEP 2413, the INSDSeq_length element in a Sequence Listing XML has specific requirements:
- It must be a positive integer
- It represents the number of residues in the sequence
- For nucleotide sequences, it includes both nucleotides and nucleotide analogs
- For amino acid sequences, it includes amino acids, modified amino acids, and unknown amino acids
MPEP 2413 states: “The length of the sequence must be indicated by a positive integer expressing the number of residues.”
This element is crucial for accurately representing the size of each sequence in the Sequence Listing XML file.
To learn more:
The element in a Sequence Listing XML serves a specific purpose in identifying the type of molecule being described. Here’s how it functions:
- It specifies whether the sequence is DNA, RNA, or protein.
- This information is crucial for proper interpretation of the sequence data.
- It helps in determining the appropriate analysis methods and tools to be used.
The MPEP 2413.01 mentions the as one of the elements within the container. By clearly indicating the molecule type, this element ensures that patent examiners and other readers can correctly understand and evaluate the sequence information provided in the application.
To learn more:
The element in a Sequence Listing XML serves a specific purpose:
- It is used to provide additional sequence identifiers for a given sequence.
- This element can contain one or more sub-elements.
- Each sub-element represents an alternative identifier for the sequence.
According to MPEP 2413.01, “The contains one or more elements identifying alternative sequences.” This allows for flexibility in referencing sequences using different identification systems or nomenclatures.
To learn more:
The element in a Sequence Listing XML contains crucial information about the actual sequence. Here’s what it includes:
- The raw sequence data itself.
- It represents the order of nucleotides (for DNA/RNA) or amino acids (for proteins).
- The sequence is presented without spaces or numbers.
According to MPEP 2413.01, “The contains the raw sequence data.” This element is essential as it provides the core information about the biological sequence being disclosed in the patent application.
To learn more:
When submitting a “Sequence Listing XML” in response to a notice from the United States International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), applicants are required to pay a late furnishing fee. According to MPEP 2414.05:
“In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required.”
This fee is in addition to the submission of the “Sequence Listing XML” and a statement that the information does not go beyond the original disclosure. The specific amount of the fee can be found in 37 CFR 1.445(a)(5) and is subject to change, so applicants should consult the current fee schedule on the USPTO website.
To learn more:
When submitting a “Sequence Listing XML” on read-only optical discs, proper labeling and packaging are crucial. According to MPEP 2413.03, follow these guidelines:
- Marking: All read-only optical discs, fees, and accompanying papers should be marked “Mail Stop SEQUENCE.”
- Hand delivery: For hand delivery to the Customer Service Window, place the disc in a protective mailer labeled with at least the application number (if available).
- Labeling requirements: Adhere to the labeling requirements of 37 CFR 1.52(e) and 1.834(b)(2).
- Packaging: Use staples and clips carefully to attach the mailer to the submitted papers without contacting or compressing the media.
- Multiple discs: If a compressed XML file doesn’t fit on a single disc, it may be split into multiple parts, labeled in compliance with § 1.52(e)(5)(vi).
The MPEP also states: “In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.”
By following these guidelines, you ensure proper handling and processing of your “Sequence Listing XML” submission.
To learn more:
Yes, applicants need to specify the term of deposit even if it’s made under the Budapest Treaty. The MPEP clearly states:
Unless applicant indicates that the deposit has been made under the Budapest Treaty, applicant must indicate the term for which the deposit has been made.
This means that if the deposit is not explicitly stated to be under the Budapest Treaty, the applicant must provide information about the term of deposit. Even for Budapest Treaty deposits, it’s advisable to clearly state the term to avoid any potential issues or misunderstandings during the examination process.
To learn more:
Patent Procedure (15)
A Sequence Identifier (SEQ ID NO) is a unique number assigned to each disclosed nucleic acid and/or amino acid sequence in a patent application. According to MPEP 2422.01:
“37 CFR 1.821(d) and 37 CFR 1.823(a)(5) require that each disclosed nucleic acid and/or amino acid sequence in the application appear separately in the “Sequence Listing”, with each sequence further being assigned a sequence identifier, referred to as “SEQ ID NO:” or the like.“
Key points about Sequence Identifiers:
- They must begin with 1 and increase sequentially by integers.
- Each sequence must have a different number for identification.
- Sequences should be presented in numerical order in the “Sequence Listing” where practical.
- When discussing a sequence in the description or claims, a reference to its SEQ ID NO is required at all occurrences.
- SEQ ID NOs can be used to discuss or claim parts of a sequence (e.g., “residues 14 to 243 of SEQ ID NO:23”).
The use of SEQ ID NOs provides a shorthand way for applicants to discuss and claim their inventions without restricting how an invention can be claimed.
To learn more:
Sequence identifiers (SEQ ID NOs) are crucial in patent applications containing nucleotide and/or amino acid sequences. According to MPEP 2421.02:
- Each disclosed nucleotide and/or amino acid sequence must be assigned a unique SEQ ID NO.
- SEQ ID NOs must be used to identify sequences in the specification, claims, and drawings.
- The SEQ ID NO should be placed adjacent to the sequence or used in a table correlating sequence names with their corresponding SEQ ID NOs.
The MPEP states: “The rules require that the sequence identifiers must be used in all instances where the sequences are disclosed in a patent application.” This ensures clear and consistent referencing of sequences throughout the application.
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The case of Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990) is mentioned in MPEP 2410.01 in the context of biological material deposits. This case is significant because it reinforces the requirement that all restrictions on access to deposited biological material must be removed upon patent grant, with only the specific exception allowed under 37 CFR 1.808(b).
The MPEP cites this case to emphasize that compliance with the Budapest Treaty alone is not sufficient to meet all U.S. requirements for biological deposits. Specifically, the MPEP states: Consequently, the mere indication that a deposit has been made and accepted under conditions prescribed by the Budapest Treaty would satisfy all conditions of these regulations except the requirement that all restrictions on access be removed on grant of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
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For patent applications filed on or after January 1, 2022, the USPTO has specific procedures for handling defective sequence listings. According to MPEP 2422.07:
“Applications filed on or after January 1, 2022, that are otherwise complete, but that contain defective sequence listings, will be accepted and the defective sequence listing will be treated in accordance with 37 CFR 1.52(e)(8).”
This means:
- The application will be accepted for filing.
- The applicant will be notified of the defective sequence listing.
- The applicant will be given a period of time to correct the defective sequence listing.
- If the defect is not corrected within the specified time, the application may be held abandoned.
It’s important to note that this procedure differs from that for applications filed before January 1, 2022, which were subject to different rules regarding sequence listing defects.
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Under the new Sequence Rules, patent applicants must submit sequence listings in a specific format. MPEP 2412.01 states that “an applicant is required to submit sequence data… in eXtensible Markup Language (XML) format.”
This XML file must conform to the requirements specified in 37 CFR 1.831 – 1.834, which in turn reference particular paragraphs of WIPO Standard ST.26. The use of XML format ensures standardization and machine-readability of sequence data across different patent offices worldwide.
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A “Sequence Listing” is a separate part of a patent application that contains disclosures of nucleotide and/or amino acid sequences, along with associated information, using a standardized format and symbols. According to MPEP 2421.01, it is required for applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a).
The MPEP states: 37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823.
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According to MPEP 2412.05(a), intentionally skipped sequences must be included in the “Sequence Listing XML” and represented as follows:
- Use the element SequenceData and its attribute sequenceIDNumber, providing the sequence identifier of the skipped sequence as the value.
- Include the elements INSDSeq_length, INSDSeq_moltype, and INSDSeq_division, but with no value provided.
- Do not include the element INSDSeq_feature-table.
- Use the element INSDSeq_sequence with the string “000” as the value.
The MPEP states: “Where no sequence is present for a sequence identifier, i.e. an intentionally skipped sequence, ‘000’ must be used in place of a sequence.” This ensures that the total number of sequences in the listing matches the total number of sequence identifiers, maintaining consistency and completeness in the documentation.
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The element in a Sequence Listing XML is used to describe features of the sequence. Here’s how it’s structured and used:
- It contains one or more elements.
- Each element describes a specific feature of the sequence.
- Features can include biological significance, such as coding regions or mutation sites.
The MPEP 2413.01 states: “The contains one or more elements.” This table allows applicants to provide detailed information about specific regions or characteristics of the sequence, which is crucial for understanding its biological function and patentability.
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What are the requirements for INSDSeq_length in a Sequence Listing XML?
According to MPEP 2413, the INSDSeq_length element in a Sequence Listing XML has specific requirements:
- It must be a positive integer
- It represents the number of residues in the sequence
- For nucleotide sequences, it includes both nucleotides and nucleotide analogs
- For amino acid sequences, it includes amino acids, modified amino acids, and unknown amino acids
MPEP 2413 states: “The length of the sequence must be indicated by a positive integer expressing the number of residues.”
This element is crucial for accurately representing the size of each sequence in the Sequence Listing XML file.
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The element in a Sequence Listing XML serves a specific purpose in identifying the type of molecule being described. Here’s how it functions:
- It specifies whether the sequence is DNA, RNA, or protein.
- This information is crucial for proper interpretation of the sequence data.
- It helps in determining the appropriate analysis methods and tools to be used.
The MPEP 2413.01 mentions the as one of the elements within the container. By clearly indicating the molecule type, this element ensures that patent examiners and other readers can correctly understand and evaluate the sequence information provided in the application.
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The element in a Sequence Listing XML serves a specific purpose:
- It is used to provide additional sequence identifiers for a given sequence.
- This element can contain one or more sub-elements.
- Each sub-element represents an alternative identifier for the sequence.
According to MPEP 2413.01, “The contains one or more elements identifying alternative sequences.” This allows for flexibility in referencing sequences using different identification systems or nomenclatures.
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The element in a Sequence Listing XML contains crucial information about the actual sequence. Here’s what it includes:
- The raw sequence data itself.
- It represents the order of nucleotides (for DNA/RNA) or amino acids (for proteins).
- The sequence is presented without spaces or numbers.
According to MPEP 2413.01, “The contains the raw sequence data.” This element is essential as it provides the core information about the biological sequence being disclosed in the patent application.
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When submitting a “Sequence Listing XML” in response to a notice from the United States International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), applicants are required to pay a late furnishing fee. According to MPEP 2414.05:
“In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required.”
This fee is in addition to the submission of the “Sequence Listing XML” and a statement that the information does not go beyond the original disclosure. The specific amount of the fee can be found in 37 CFR 1.445(a)(5) and is subject to change, so applicants should consult the current fee schedule on the USPTO website.
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When submitting a “Sequence Listing XML” on read-only optical discs, proper labeling and packaging are crucial. According to MPEP 2413.03, follow these guidelines:
- Marking: All read-only optical discs, fees, and accompanying papers should be marked “Mail Stop SEQUENCE.”
- Hand delivery: For hand delivery to the Customer Service Window, place the disc in a protective mailer labeled with at least the application number (if available).
- Labeling requirements: Adhere to the labeling requirements of 37 CFR 1.52(e) and 1.834(b)(2).
- Packaging: Use staples and clips carefully to attach the mailer to the submitted papers without contacting or compressing the media.
- Multiple discs: If a compressed XML file doesn’t fit on a single disc, it may be split into multiple parts, labeled in compliance with § 1.52(e)(5)(vi).
The MPEP also states: “In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.”
By following these guidelines, you ensure proper handling and processing of your “Sequence Listing XML” submission.
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Yes, applicants need to specify the term of deposit even if it’s made under the Budapest Treaty. The MPEP clearly states:
Unless applicant indicates that the deposit has been made under the Budapest Treaty, applicant must indicate the term for which the deposit has been made.
This means that if the deposit is not explicitly stated to be under the Budapest Treaty, the applicant must provide information about the term of deposit. Even for Budapest Treaty deposits, it’s advisable to clearly state the term to avoid any potential issues or misunderstandings during the examination process.
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