How should variable-length regions in sequences be represented in a Sequence Listing?

Variable-length regions in sequences should be represented in a Sequence Listing as follows: Repeat the variable-length region as many times as the maximum length. Specify in the Features section that the amino acid (or nucleotide) at a specified position is either absent or present. The MPEP provides this guidance: Sequences that have variable-length regions depicted…

Read More

How should intentionally skipped sequences be represented in the “Sequence Listing XML”?

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…

Read More

Is there a difference in replacing deposits during patent application versus after grant?

Yes, there is a difference in the flexibility allowed for replacing deposits during the patent application process compared to after the patent has been granted. The MPEP notes: “An applicant may have greater latitude in replacing a deposit during the pendency of an application than after the patent is granted.” This suggests that applicants have…

Read More

What is required when submitting a replacement “Sequence Listing XML” under 37 CFR 1.835(b)?

When submitting a replacement “Sequence Listing XML” under 37 CFR 1.835(b), the following items are required: A compliant replacement “Sequence Listing XML” file An amendment to the specification incorporating the new file by reference A statement identifying the location of all changes A statement identifying the basis for all changes A statement that no new…

Read More

What does “replacement” mean in the context of biological material deposits?

In the context of biological material deposits, “replacement” refers to situations where one deposit is being substituted for another. The MPEP states: “The term ‘replacement’ is directed to those situations where one deposit is being substituted for another. Replacement will typically take place where the earlier deposit is no longer viable.” This usually occurs when…

Read More

What are some reasons for supplementing a biological deposit?

Supplementing a biological deposit may be necessary when the original deposit has lost certain qualities but remains viable. The MPEP provides examples: “The term ‘supplement’ is directed to those situations where the earlier deposit is still viable in the sense that it is alive and capable of replication either directly or indirectly, but has lost…

Read More

How does the reasonable expectation of success requirement apply in unpredictable arts?

The reasonable expectation of success requirement applies to all fields of invention, but it can be more challenging to establish in unpredictable arts, such as biotechnology or pharmaceuticals. In these fields, the level of predictability is generally lower, which can affect the analysis of obviousness. The MPEP 2143.02 provides guidance on this issue, citing relevant…

Read More

What is the purpose of the sequence rules in patent applications?

What is the purpose of the sequence rules in patent applications? The sequence rules in patent applications serve several important purposes, as explained in MPEP 2412.01: “The sequence rules […] set forth a standardized format for describing nucleotide and amino acid sequences in patent applications. This standardized format allows for the presentation of such sequences…

Read More