Failure to reply to Han Chunyu's gene editing patent "deemed withdrawn" within the prescribed time limit"

According to the State Intellectual Property Office, the patent with Han Chunyu, associate professor of Hebei University of Science and Technology, and Shen Xiao, a researcher at the School of Basic Medicine of Zhejiang University, as inventors-the gene editing technology with Argonaute nuclease as the core, because the applicant did not reply within the prescribed time limit The notice of the first review opinion of the national intellectual property rights, the patent application is deemed to be withdrawn. On January 9, 2017, the State Intellectual Property Office issued the "Notice of Deemed Withdrawal" of the patent application ".

The core content of the patent is the NgAgo gene editing technology published by Han Chunyu's research group in the journal Nature Biotechnology on May 2, 2016. The paper, entitled "DNA-guided genome editing using the Natronobacterium gregoryi Argonaute (DNA-guided genome editing using Enuclease from Halophilus Grignard)", has aroused widespread academic discussion since its online publication.

The paper describes the method of gene editing by using DNA to mediate NgAgo's recognition of targeted genes, which was once considered to be the fourth generation of gene editing technology after CRISPR-Cas9. Compared with CRISPR-Cas9 searching for replacement sequences through RNA, Han Chunyu's NgAgo is more accurate in searching for replacement targets through DNA. Because NgAgo's fault tolerance rate is very low, mismatching one base will reduce the efficiency by NgAgo73 -100%. When three bases are mismatched, NgAgo's effect basically disappears, effectively avoiding "off-target". However, the CRISPR-Cas9 can tolerate up to 5 base mismatches, which greatly reduces the modification efficiency. As for the initiation of the cutting event, Han Chunyu said in his report that NgAgo was limited only by GC abundance, while CRISPR-Cas9 was limited by PAM region and GC-rich sequence. NgAgo also achieved good gene editing results in human 293T, MCF7, K562 and Hela cells. In addition, NgAgo can not only accurately insert the target gene, but also perform NHEJ (non-homologous end joining) with good efficiency in inserting the target DNA fragment.

According to related reports, the automatic withdrawal of the patent was the applicant's decision. They knew about the withdrawal. They did not choose to reply, so that the automatic deadline for the withdrawal of the patent was reached.

According to the data, on December 21, 2015, exactly half a year after the submission to "Nature-Biotechnology", the patent for this paper began to be applied. Shen Xiao also explained that he was very anxious to write a patent at that time, so that the applicant only wrote Zhejiang University. In addition, among the nine nucleases listed in the claims, the gene sequence numbers of two nucleases are repeated, but in fact only eight nucleases are listed, thus showing the rush of patent applications.

On May 11, 2016, the patent entered the substantive examination stage. On June 6, 2016, the State Intellectual Property Office issued a "Notice of First Examination Opinions" on this patent application ". Then, because the applicant replied within the prescribed time limit, the State Intellectual Property Office and the 9th of this month issued the "deemed withdrawal notice" of the patent application ".

But this does not mean that the patent application has failed. Because in accordance with the provisions of Article 6 of the "Detailed Rules for the Implementation of the Patent Law of the People's the People's Republic of China of China" and the prompt of the "Notice of Deemed Withdrawal", Han Chunyu and Shen Xiao can submit a request for restoration of rights within two months, explain the reasons, and go through the rights before loss. The corresponding procedures. If the party concerned requests the restoration of his rights due to other justifiable reasons, he shall also pay a fee of 1000 yuan for the restoration of his rights. If the above operation is not carried out within the prescribed two months, the patent application will become invalid.

In addition, with the escalating controversy over the repeatability of NgAgo experiments, the patent issue of NgAgo technology has also been widely concerned because it involves commercial interests. Article 22 of the the People's Republic of China Patent Law stipulates that inventions and utility models for which patent rights are granted shall be novel, inventive and practical. Practicality means that the invention or utility model can be made or used and can produce positive effects. NgAgo, which is still in the vortex of repeatability disputes, may have to accept the test of "practicality" if it wants to obtain a patent license.

News source:http://news.bioon.com/article/6697284.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.