Patent decision

BL number

O/077/11

Concerning rights in

GB 1010504.7

Hearing Officer

Dr L Cullen

Decision date

25 February 2011

Person(s) or Company(s) involved

Yung-Hsiang Liu, Wing-Lee Chan, Yuan-Feng Lin

Provisions discussed

PA 1977; sections 14(3), 14(5) and 18(5)

Keywords

Divisional application, Sufficiency, Support

Related Decisions

None

Summary

The application in question is a divisional application and relates to a process for generating multipotent stem cells by de-differentiating mononucleated cells. The specification provides an example of activating the enzyme, protein kinase C ß2 iso-form (PKC-ß2), in mononucleated cells by applying two compounds in sequence, Go6976 and then Bryostatin-1, to cultures of these cells which then gave rise to multipotent stem cells. The specification also gives an example of the generation of multipotent stem cells from mononucleated cells by the addition of two compounds, GM-CSF and SDF-1, at the same time. The parent application had been granted (GB2426765B) and its main claim relates to a process for producing multipotent stem cells from mononucleated cells using Go6976 and Bryostatin-1.

The applicants’ main argument is that their inventive contribution was the observation that only a particular iso-form of protein kinase C, PKC-ß2, is necessary for de-differentiation of mononucleated cells to produce multipotent stem cells. This is reflected in the main claim which is to a process for producing multipotent stem cells from mononucleated cells involving the activation of the PKC-ß2 iso-form. The applicants claim this was a “principle of general applicability” and submitted that the application provided an enabling disclosure and experimental evidence to support the full breadth of this claim.

The Hearing Officer (HO) held that, while the application provided evidence for the activation of the PKC-ß2 iso-form using Go6976 and Bryostatin-1 in sequence, this was not adequate to support the full breath of the main claim, i.e., that multipotent stem cells are obtained from mononucleated cells via the activation of the PKC-ß2 iso-form. There is a lack of evidence in the specification of the involvement of the PKC-ß2 iso-form in the protocol that involved adding GM-CSF and SDF-1 at the same time. The HO considered that the skilled person would be under an undue burden to determine whether a specific compound or combination of compounds would activate the PKC-ß2 iso-form and so achieve the result of the main claim, i.e., de-differentiation of mononucleated cells to produce multipotent stem cells. Consequently it was held that the main claim was insufficient because the application provided only one protocol to activate the PKC-ß2 iso-form. The HO found, in addition, that some of the claims were coterminous with the claims of the parent application and held therefore they related to the same invention as claimed in the parent patent. As a consequence, the application was refused for lack of support and insufficiency under Sections 14(3) and 14(5)(c) and for conflict with the granted parent under section 18(5), PA 1977.