During the prosecution of European patent application 05028411.6, the Examining Division objected to claims relating to obtaining pluripotent stem cells from an embryo. Claim 1 of the rejected application is directed to a method for obtaining pluripotent embryonic stem cells in an embryo preserving manner from blastocysts. After an initial positive Communication from the Examining Division, the application was rejected since the Examiner argued that the claims contravened R. 28 (c) EPC which stipulates that patents shall not be granted for biotechnological inventions concerning the use of human embryos for industrial or commercial purposes.
The Examining Division outlined that the claim comprised the use of embryos that are needed as a “starting material” to perform the claimed method for industrial and commercial purposes. Referring to decision G 2/06 (the “WARF” decision) the Examining Division also indicated that the non-destruction of the embryo in the claimed method was of no importance and, moreover, the claimed method was of no benefit to the embryo itself.
On appeal (T1836/10), the Applicant argued that there should be an exemption from the exclusion from patentability, if the invention is directed to diagnostic or therapeutic purposes, which would both be possible in the case at hand. The obtained cells could be used for means of pre-implantation diagnosis and the cells could equally be used at a later stage for therapeutic purposes for the human that developed from the embryo. The Board of Appeal maintained the Examining Division’s objection since the diagnostic or therapeutic purposes as suggested by the Applicant were not derivable as such from the claims. In reply, the Applicant filed a new claim-set with a disclaimer excluding the use of the obtained stem cells for industrial and commercial purposes.
Consequently, the question to be considered was whether the introduction of such a disclaimer was allowable. In the case at hand, the disclaimer had no specific basis in the application as originally filed. The Board rejected the amendment because the disclaimer would only be allowable if it indeed excluded subject-matter which was otherwise claimed. In the case at hand, the only claim without the disclaimer was directed to a method for obtaining embryonic stem cells, which were the “direct products” of the method. However, the disclaimer excluded merely the future use of the obtained stem cells. Thus, the Board held that the amendment sought to exclude subject-matter not covered by the claims and therefore in effect would not be limited by the disclaimer. The appeal was therefore rejected.
Recommended Practice Points
As appears clear from the Board of Appeal, the issue of exclusion from patentability appears to be independent of the fact whether the embryo is actually destroyed during its use or not. As a result, the only exception from the exclusion of patentability appears to be when the embryo benefits from its own use, i.e. when it is used for its own diagnostic or therapeutic purposes. The step providing this benefit would, however, appear to have to be claimed. Care should therefore be taken when drafting patent applications to inventions involving the use of human embryos to specify diagnostic and therapeutic benefits in the application.
When drafting new applications, consideration should be given to the inclusion of a disclaimer to the effect that the stem cells are not for commercial or industrial use to provide specific basis should it be required during prosecution.
http://www.aipla.org/committees/committee_pages/Biotechnology/international/Shared%20Documents/International_Buzz_201312b.pdf