When did the new requirements for “specifically defined” nucleotides and amino acids come into effect?
According to MPEP 2412.03(a), the new requirements for “specifically defined” nucleotides and amino acids came into effect for patent applications filed on or after July 1, 2022. The MPEP states: [Editor Note: This section is applicable to all applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as…
Read MoreHow should coding regions be depicted in patent applications?
According to 37 CFR 1.822(c)(3), if an applicant chooses to depict coding regions, the amino acids corresponding to the codons in the coding parts of a nucleotide sequence must be listed immediately below the corresponding codons. The MPEP states: “If applicant chooses to depict coding regions, 37 CFR 1.822(c)(3) requires the amino acids corresponding to…
Read MoreHow does the MPEP define “AP sites” or “abasic sites” in nucleotide sequences?
The MPEP 2412.03(d) addresses “AP sites” or “abasic sites” in the context of nucleotide sequences. According to the MPEP: “[A nucleotide can be] lacking a purine or pyrimidine nucleobase when the nucleotide is part of a nucleotide sequence, referred to as an ‘AP site’ or an ‘abasic site’.” In other words, an AP site or…
Read MoreHow should ambiguity symbols be used in nucleotide sequences?
The MPEP 2423.01 provides guidance on using ambiguity symbols in nucleotide sequences: “For those nucleotides that are ambiguous in designation, the list of one-letter codes given in WIPO Standard ST.25 (1998), Appendix 2, Table 2, must be used.” Some common ambiguity symbols include: n – a or c or g or t/u r – a…
Read MoreHow does the USPTO handle restriction requirements for nucleotide sequences in national applications?
For national applications filed under 35 U.S.C. 111(a), the USPTO handles restriction requirements for nucleotide sequences according to the standards in MPEP Chapter 800. As stated in MPEP 803.04: “For national applications filed under 35 U.S.C. 111(a), polynucleotide inventions will be considered for restriction, rejoinder, and examination practice in accordance with the standards set forth…
Read MoreWhat is the USPTO’s current policy on nucleotide sequences in patent applications?
The USPTO’s current policy on nucleotide sequences in patent applications is based on the 2007 Official Gazette notice, which rescinded the 1996 waiver that allowed multiple nucleotide sequences in a single application. According to MPEP 803.04: “In 2007, the Commissioner for Patents rescinded the waiver. See Examination of Patent Applications Containing Nucleotide Sequences, 1316 OG…
Read MoreHow does unity of invention apply to nucleotide sequences?
Unity of invention for nucleotide sequences in PCT applications is addressed specifically in MPEP 1850. The key points are: Nucleotide sequences encoding the same protein are considered to satisfy the unity of invention standard and will continue to be examined together. This is an exception to the general rule that requires “one or more of…
Read MoreHow are polynucleotide molecules defined by their nucleic acid sequence treated in patent applications?
Polynucleotide molecules defined by their nucleic acid sequence, also known as nucleotide sequences, are treated as structurally distinct chemical compounds in patent applications. According to MPEP 803.04: “Polynucleotide molecules defined by their nucleic acid sequence (hereinafter “nucleotide sequences”) that encode different proteins are structurally distinct chemical compounds. These sequences are thus deemed to normally constitute…
Read MoreHow are nucleotide sequences treated in international patent applications under the PCT?
The treatment of nucleotide sequences in international patent applications filed under the Patent Cooperation Treaty (PCT) differs from national applications. According to MPEP 803.04: “See MPEP § 1850 for treatment of claims containing independent and distinct nucleotide sequences in international applications filed under the Patent Cooperation Treaty (PCT) and national stage applications filed under 35…
Read MoreWhat is the EPO’s policy on nucleotide and amino acid sequences in international applications?
What is the EPO’s policy on nucleotide and amino acid sequences in international applications? The European Patent Office (EPO) has specific requirements for international applications containing nucleotide and/or amino acid sequences: According to the MPEP: Where an international application contains disclosure of nucleotide and/or amino acid sequences, the EPO will search the international application to…
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