Are there additional fees for submitting large Sequence Listing files?
Yes, there are additional fees for submitting large Sequence Listing files to the USPTO. The fee structure is as follows: Sequence Listing ASCII plain text files of 300 MB or more are subject to a fee under 37 CFR 1.21(o). The fee is divided into two tiers: Tier 1: File sizes 300 MB to 800…
Read MoreHow does the USPTO determine if a biological deposit is necessary for a patent application?
The necessity of a biological deposit is determined on a case-by-case basis by the USPTO. According to MPEP 2403: “For the most part, this issue must be addressed on a case-by-case basis.” The examiner evaluates whether the deposit is needed to satisfy the statutory requirements for patentability, particularly the enablement requirement under 35 U.S.C. 112(a).…
Read MoreHow does the USPTO determine if a Sequence Listing XML is “non-lengthy”?
The USPTO determines if a Sequence Listing XML is “non-lengthy” based on the size of the ASCII text file produced after transforming the XML file. According to MPEP 2419.01: “Upon transformation of the .xml file using the style sheet to an ASCII text file, any ASCII text file produced by the USPTO that is under…
Read MoreHow does the USPTO determine if a biological material is known and readily available?
The USPTO determines if a biological material is known and readily available based on several factors: Public availability of the material Ability to reproduce the material from the written description Accessibility without undue experimentation MPEP 2404 states: “The USPTO will accept commercial availability as evidence that a biological material is known and readily available only…
Read MoreHow does the USPTO define direct self-replication of biological materials?
The United States Patent and Trademark Office (USPTO) defines direct self-replication of biological materials in MPEP 2403.01 as follows: “Direct self-replication includes those situations where the biological material reproduces by itself.” This means that the biological material can reproduce independently, without requiring the presence of another self-replicating biological material. The MPEP indicates that representative examples…
Read MoreHow does the USPTO determine if a biological material is “known and readily available”?
How does the USPTO determine if a biological material is “known and readily available”? The USPTO considers several factors to determine if a biological material is “known and readily available,” which may negate the need for a deposit. According to MPEP 2404: “The Office will accept commercial availability as evidence that a biological material is…
Read MoreHow does the USPTO determine if a depository is acceptable?
The United States Patent and Trademark Office (USPTO) has specific criteria for determining if a depository is acceptable for biological materials. According to MPEP 2405: “The Commissioner may determine that a depository is acceptable if the depository:” Maintains biological material viability for 30 years or 5 years after the most recent request, whichever is longer…
Read MoreHow does the USPTO handle confidentiality of sequence data in pending applications?
The USPTO maintains strict confidentiality of sequence data in pending applications, in compliance with 35 U.S.C. 122. The MPEP clarifies: It should be noted that the Office’s database complies with the confidentiality requirement imposed by 35 U.S.C. 122. Unpublished pending application sequences are maintained in the database separately from published or patented sequences. That is,…
Read MoreWhat are the size restrictions for ASCII plain text files submitted via the USPTO patent electronic filing system?
The USPTO has specific size restrictions for ASCII plain text files submitted via their patent electronic filing system: The size limit for “Sequence Listing” ASCII plain text files is 100 megabytes. Compression is not allowed for “Sequence Listing” files submitted via the USPTO patent electronic filing system. For “Large Tables” and “Computer Program Listing Appendix”…
Read MoreHow should the <213> numeric identifier be used in a sequence listing?
The numeric identifier in a sequence listing has a specific use according to the Manual of Patent Examining Procedure (MPEP). As stated in MPEP 2424.02: “ is used for the name of the organism from which the sequence was obtained” This means that when providing a sequence listing, you should use the identifier to specify…
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