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Intellectual Property High Court (IPHC) expresses its interpretation of “invention described in the written description of prior application” set forth in Japanese Patent Act Article 29bis, cancelling judgment of Board of Appeal.

1. Background
Plaintiffs (Broad Institute and MIT) filed a patent application for “CRISPR-Cas system and method for modifying the expression of gene products” on June 29, 2016 (Japanese Patent Application No. 2016-128599) claiming a 
convention priority of December 12, 2012 (US).  The examiner rejected the claimed invention under Article 29bis on the ground that the claimed invention was described in a prior application filed previously but published after the
present application, and that decision was upheld by the board of appeal (along with finding the claims obvious). 
The plaintiffs filed a lawsuit before the Intellectual Property High Court (IPHC) on January 29, 2017, challenging the board’s decision.  What is at issue in this suit is whether the rejection under Article 29bis is appropriate.

2. Claim at issue
Claim 1 at issue reads as follows: (hereinafter the invention in claim 1 is referred to as “Present Invention”.)

Claim 1: An engineered, non-naturally occurring Clustered Regularly Interspersed Short Palindromic Repeats
(CRISPR)-CRISPR associated (Cas) (CRISPR-Cas) vector-system comprising one or more vectors comprising:
(a) a first regulatory element operably linked to one or more nucleotide sequence(s) encoding one or more
CRISPR-Cas system guide RNA(s) which hybridize to a target sequence in a locus in a eukaryotic cell, wherein the
guide RNA includes a guide sequence, a tracr sequence and a tracr mate sequence, and
(b) a second regulatory element operably linked to a nucleotide sequence encoding a Type II Cas9 protein,
　　　 wherein the protein includes a nuclear localization signal (NLS), wherein components (a) and (b) are located on the same or different vectors of the system, and the tracr sequence is 30 or more nucleotides in length,
 　　　by which the guide sequence targets one or more polynucleotide loci in a eukaryotic cell, and the Cas9
protein cleaves the one or more polynucleotide loci,
 　　　by which sequence of the one or more polynucleotide loci is modified.

3. JPO Board of Appeal’s Decision
The board of appeal held, among other things, that the present invention is unpatentable under Article 29bis as it is the same as an invention described in PCT/US2013/073307, filed on December 5, 2013 with a priority date of
December 6, 2012 and published as WO 2014/089290 (‘290 patent) on June 12, 2014.  The board of appeal found
that “the ‘290 patent recites an invention (cited invention) which is directed to a vector system, comprising:
　　　 vector including a promoter control sequence, operably linked to a nucleic acid encoding for at least one
Type II Cas9 protein comprising at least one nuclear localization signal;
　　　 vector including promoter control sequence operably linked to DNA coding for at least one guide RNA
comprising the first region at 5′ terminal that is complementary to a target site in the chromosomal sequence in a
eukaryotic cell, the second internal region in stem-loop structure and the third region which is essentially single
chain, and
 　　　vector including at least one donor polynucleotide, wherein the guide RNA derives Type II Cas9 protein into the target site in the chromosomal sequence in a eukaryotic cell, the Type II Cas9 protein derives the cleavage of the double strand DNA of the chromosomal sequence at the target site and the cleavage of the double strand DNA is
restored in the restoration process as the chromosomal sequence is restored.”

The board of appeal also found that ‘the present invention recites “the traced sequence is 30 or more nucleotides in length” (the lower limit).  In contrast, the ‘290 patent does not specify the length of the tracr sequence, and it only
says that the total length of “the second and the third regions” including “tracr and tracr mate sequence” is
approximately 30 to 120 nucleotides, which in turn means that the cited invention includes a vector system of
which a sequence portion corresponding to the tracr sequence of the present invention is not only less than 30
nucleotides in length but also more than 30 nucleotides in length.’

4.  Decision of IP High Court
a. Interpretation of Patent Act Article 29bis
The IPHC found that ‘an “invention” described in the prior application set forth in Article 29bis covers an invention
that is derived from not only what is explicitly described but also what is considered to be described, in the prior
application.  What is considered to be described should be interpreted as that derived from the description of the
prior application in light of technical common knowledge at the time of filing the application.

The present invention is characterized in that the tracr sequence is limited to 30 or more nucleotides in length
based on the inventor’s findings that the length of the tracr sequence is critical to the efficiency of gene
modification.

In contrast, the ‘290 patent discloses that
– guide RNA includes three domains from the first domain to the third domain;
– the length of the stem may be from approximately 6 to 20 base pairs in length;
– typically, the third domain is approximately 4 or more nucleotides in length, and for example, the length of the
third domain is in the range from approximately 5 to 60 nucleotides in length; and
– the total length of the second and third domain of the guide RNA can be in the range from approximately 30 to
120 nucleotides in length.

Also, considering the description of the present application that “a part of the sequence of the 3′ side of the loop
corresponds to the tracr sequence”, the “tracr sequence” of the present invention is thought to be a combination of the third domain and one side of the stem in the second domain; however, the ‘290 patent does not have any idea
of specifying the length of the tracr sequence (combination of the third domain and one side stem of the second
domain) as one element of its patent claim.

Further, no evidence shows that there was technical common knowledge at the time of priority date that the length of the tracr sequence should be made to be 30 or more nucleotides in length.

Accordingly, the cited document fails to teach or suggest that “the tracr sequence is 30 or more nucleotides in
length” or does not seem to disclose this feature even in light of technical common knowledge at the time of
priority date.’

c. Arguments by Defendant
The defendant argued that “no difference could be found between guide RNA (+48) having the tracr sequence of 26 nucleotide length and guide RNA (+54) having the tracr sequence of 32 nucleotide length, both targeting proto
spacer 2, 4 and 5.  Also, the present invention in which the tracr sequence is 30 or more nucleotides in length does
not have any advantage that improves the gene modification efficiency without depending on the target sequence.  Therefore, the present invention does not provide any new advantage over the cited invention.”

The IPHC disagreed, finding that the specification shows that chimeric RNA (+54) having a tracr sequence of 32
nucleotides provides an enhanced gene modification efficiency over chimeric RNA (+48) having a tracr sequence of 26 nucleotides, for different targeting sequences such as proto spacer 1 and 3, so that it cannot be said that there is no possibility that the present invention of which the tracr sequence is 30 or more nucleotides in length increases
the gene modification efficiency of a eukaryotic cell for other targeting sequences other than proto spacers 1 and 3.

5. Comments
This case relates to a hot genomic editing technology.  In this judgement, the IPHC expressed its interpretation of “an invention described in the written description of prior application” set forth Article 29bis, and, based on this
interpretation, vacated the board’s decision and found the claims patentable.

In some cases, the Examiner may say that a claimed invention is substantially the same as an invention disclosed in a cited document even though there exists some difference between the present invention and the cited invention.  One strategy that the applicant may take in this instance is to argue that the claimed invention provides new
advantages over the cited invention.  Typically, the new advantages may be shown by submitting experimental
data.  In some cases, however, the experimental data may not be entered.  This decision indicates that, even in
those instances, the claimed invention can be patented if it is distinguishable over the cited invention by
considering the possible advantages.

Regarding the “substantially the same standard” in connection with Article 29bis, the examination guideline says
that this standard applies if the difference between the claimed invention and the cited invention is small, i.e., if the difference is a mere addition or replacement of well-known technology and therefore the claimed invention does
not provide a new and advantageous effect over the cited invention.  See Examination Guideline, Part III, Chapter 3, “Enlarged Concept of Novelty”, “3. Requirements of Article 29bis.”

An accumulation of court decisions is highly expected in order to enhance the foreseeability in determining what
types of effects are entered and persuasive in arguing for the patentability of the claimed invention.

For reference, the IPHC issued a remarkable decision H31 (Gyo-ke) 10010 on the same day, in which the court
rejected the plaintiff’s argument, holding that claimed invention directed to genome editing technology is unpatentable under Article 29bis.

https://www.ip.courts.go.jp/app/files/hanrei_jp/261/089261_hanrei.pdf