What format is required for submitting sequence listings under the new rules?

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…

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How does the written description requirement apply to biological deposits in patent applications?

The written description requirement, as applied to biological deposits in patent applications, is based on 35 U.S.C. 112(a). According to MPEP 2411.01: “A rejection for lack of written description typically arises in the context that the application as filed does not contain a description to support an amendment to the specification or claims, although it…

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How does the written description requirement apply to genus-species claims in patent applications?

How does the written description requirement apply to genus-species claims in patent applications? The written description requirement for genus-species claims in patent applications is particularly important and often scrutinized. According to MPEP 2163: “For generic claims, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the…

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How do working examples in a patent specification affect enablement?

Working examples in a patent specification play a crucial role in demonstrating enablement, especially in unpredictable fields like biotechnology and chemistry. The MPEP Section 2164.06(b) provides insights on how courts evaluate working examples: In the In re Wands case, the court found that “the applicant carried out the entire procedure for making a monoclonal antibody…

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What is WIPO Standard ST.26 and how does it relate to patent applications?

WIPO Standard ST.26 is an international standard that defines the format and content requirements for nucleotide and amino acid sequence listings in patent applications. It was developed by the World Intellectual Property Organization (WIPO) to standardize the presentation of sequence information across different patent offices globally. According to MPEP 2412.02(a), WIPO Standard ST.26 is incorporated…

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What are the key differences between WIPO ST.25 and the new sequence rules for applications filed after July 1, 2022?

The MPEP 2420 indicates a significant change in the rules governing sequence disclosures in patent applications filed on or after July 1, 2022. The section states: “[Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR…

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What are the WIPO ST.25 sample statements for sequence listings?

The MPEP provides sample language for statements required to support sequence rule submissions under WIPO ST.25. These statements are examples and not exhaustive. They primarily cover three areas: Asserting that the sequence information in the PDF or physical sheets is identical to the computer readable form Stating that amendments adding a sequence listing are supported…

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Where can I find a sample sequence listing under WIPO ST.25?

MPEP § 2431 mentions the availability of a sample sequence listing: “A sample ‘Sequence Listing’ is included below.” While the actual sample is not provided in the given excerpt, it’s typically included in the full MPEP section. For the most up-to-date and complete information, including the sample sequence listing, you should refer to the official…

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