Key points
- The patentee appeals. Claim 1 of Auxiliary Request 2 reads as follows:
" A bone regenerative material comprising calcium sulfate [or some other compounds] for use in a method of treating a patient suffering from a degenerative bone condition that can be characterized by a loss of bone mineral density (BMD), the method comprising: forming a channel into the interior of a localized area of intact bone, using the channel as access, forming a void of dimensions greater than the channel in the localized area of intact bone by clearing degenerated bone material and optionally removing a portion of the degenerated bone material, at least partially filling the formed void with a bone regenerative material that facilitates formation of new, non-degenerated bone material in the void." - The feature in italics is added compared to the main request.
- As a comment, I note that the claim specifies " the method comprising ... filling the formed void with a bone regenerative material", not "the bone regenerative material" .
- The OD found that "The method defined in the claim did not involve a new technical teaching, as required by decision G 02/08, and was thus not novel. Therefore the claim had to be read as defining compositions suitable for this method. Since the materials defined in the claim are well-known ... the claim was then held to lack novelty"
- In connection with the Main Request, the Board notes that "it was uncontested that the material used in D3 is according to the claim. It was likewise uncontested that the method used in D3 is according to the claim."
- " D3 states clinical trials to be under way, however, no results of any such trial are on file."
- " The appellant [proprietor] defended novelty of the claim arguing that D3 failed to disclose the formation of "non-degenerated bone material" as required by the claim." This argument fails.
- "The description of the patent does not support the interpretation of "non-degenerated bone material" as exclusively referring to bone material corresponding to a 30-year old healthy subject, or bone material having certain physical characteristics relating to the BMD or T-score. The feature "new, non-degenerated bone material" may as well be interpreted as relating to newly formed bone material not yet affected by degenerative processes, as brought forward by the respondent [opponent]. In that sense the respondent's argument that newly formed bone material is, by definition, non-degenerated, has some merit."
- On the general interpretation of second medical use claims: After assuring that the method defined in the claim falls under the exclusion of Article 53(c) EPC, the use and the method steps are considered as limiting features of the claim. Following this approach it then has to be examined whether the specific use of the substance or composition defined in the claim is novel or not. If this specific use is already known, the claim is not novel over the document disclosing the specific use of the substance or composition defined in the claim."
- "The approach proposed by the appellant, i. e. reading the claim as it is drafted, assuring that the method falls under Article 53(c) EPC, then considering the use and method features as limiting and assessing whether the specific use defined by them is already known from the prior art is, in the Board's view, aligned with the wording of Article 54(5) EPC and follows its logic. ... This approach is also the one generally used by EPO departments when assessing patentability of second medical use claims, and the Board will adhere to it in the present decision."
- Turning to AR-2: "D3 does not disclose forming a channel and using this channel as an access to form a void greater than the the channel in the bone. In D3 a hole is drilled, and nothing more, see figure 3."
- "Requiring additional surgical steps clearly provides a new technical teaching compared to the disclosure of D3 already because additional physical actions must be undertaken. The method defined in the claim is thus not just verbally different from the method disclosed in D3, but differs in tangible, physical method steps."
- On inventive step: "A skilled person, reading D3, would have had no reason to create a bigger void inside the bone, using the channel as an access. There is no indication anywhere in D3 that the drill hole alone could not accommodate the bone graft material injected into the bone, or that the amount of injected material was considered insufficient. "
- "The least ambitious technical problem that can be formulated starting from D3 is the provision of an alternative treatment of bone degenerative diseases."
- The Board does not expressly reject the more ambitious problem.
- The claim is considered to be inventive.
- By way of brief comment: a claim for a device for a surgical method does not benefit from Art.54(5) as a device is not a substance; and some other decisions reject claims for a gel for a medical use because the gel had no therapeutic activity in the method. This claim escapes all traps.
EPO
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2023/08/t-055820-compound-for-surgical-method.html
