Key points
- Claim 1 is a second medical use claim directed to basically an AAV vector comprising a therapeutic gene for use in a method for treating a motor neuron disorder in a subject. The AAV vector is further specified, as well as the mode of administration. The therapeutic gene is defined as “wherein the therapeutic gene is operably linked to a promoter specific or functional in motor neurons”. The claim further specifies a functional feature described below.
- Novelty over D2 is considered. “Document D2 discloses the same scAAV9 vector, therapeutic genes, motor neuron disorders to be treated ... including the same mode of administration as referred to in claim 1 ... Document D2 further discloses ubiquitous promoters, like CMV ... which as shown in the patent, are functional in motor neurons too.”
- “It was contested between the parties whether or not document D2 discloses motor neurons transfected by the scAAV9 vector.”
- "The claim inter alia specifies that the administration of these vectors cause "infection of spinal cord motor neurons and expression of the gene in spinal cord motor neurons". Accordingly, the claimed use of the scAAV9 vectors is defined by a functional feature that indicates the desired result to be achieved, namely the transfection of spinal cord motor neurons as a necessary prerequisite to achieve a therapeutic effect. According to the case law, functional features are technical features of the claim (see Case Law, II.A.3.4., II.C.7.2.). As set out above, document D2 does not disclose the transfection of motor neurons. Thus, the "result-to-be-achieved" feature in claim 1 relates to a new technical effect."
- “ document D2 is silent on directly transfecting motor neurons, and relates to the transfection of other target cells that, after secretion of a therapeutic product, have an indirect effect on cells involved in the development of particular diseases, inter alia, SMA. The respondents did not dispute that a scAAV9-based therapy that did not directly transfect motor neurons was not suitable for treating SMA. In these circumstances document D2 provides a non-enabling disclosure for the treatment of SMA. Since for the reasons outlined above, the new mechanism of action creates a new clinical situation, the board concludes that the situation in the present case differs from that underlying the decisions T 433/14 and T 406/06.”
- The claims are found to be novel, inventive, and allowable.
T 2218/16 -
https://www.epo.org/law-practice/case-law-appeals/recent/t162218eu1.html
Claim 1 of the main request reads:
"1. An AAV vector comprising a therapeutic gene for use in a method for treating a motor neuron disorder in a subject, wherein said AAV vector is administered by by intraperitoneal (i.p.), intramuscular (i.m.) or intravenous (i.v.) injection, preferably intravenous injection, to said subject, said administration causing infection of spinal cord motor neurons and expression of the gene in spinal cord motor neurons, wherein said AAV vector is:
- a double-stranded self-complementary AAV9 vector, or
- a pseudotyped AAV vector comprising a double-stranded self-complementary AAV genome derived from an AAV serotype different from the AAV9 serotype and a capsid derived from an AAV9 capsid; and
wherein the therapeutic gene is operably linked to a promoter specific or functional in motor neurons".
Reasons for the Decision
Novelty
40. In a first line of argument, the appellant submitted that the subject-matter of claim 1 lacked novelty over documents D1 and D2. Since, as the appellant further submitted, the disclosure of both documents is "very similar, if not identical", in the following reference will be made to relevant passages in document D2 only.
40.1 Document D2 discloses the same scAAV9 vector, therapeutic genes, motor neuron disorders to be treated (e.g. SMA, amyotrophic lateral sclerosis (ALS), or Kennedy's disease), including the same mode of administration as referred to in claim 1 (see for example page 1, first paragraph; page 6, lines 1 to 3, 17 to 19; page 12, lines 3 to 10 and 15 to 23). Document D2 further discloses ubiquitous promoters, like CMV (see page 9, lines 17, 27 and 28), which as shown in the patent, are functional in motor neurons too. The board is therefore not convinced by the respondents' argument, that document D2 discloses a promoter subset that is different from the "functional" promoters cited in claim 1.
source http://justpatentlaw.blogspot.com/2021/09/t-221816-gene-therapy-and-result-to-be.html
