In Reexamination Decision No. 68977 (case No. 1F137820), a rejection of lacking sufficient disclosure is overturned by the Patent Reexamination Board (PRB). The concerned patent application No. 200680043903.1 relates to a transgenic aloe plant for production of protein and the related method. In particular, claim 1 asks for a method for producing in a plant a protein exogenous to the plant, said method comprising:
- providing a transgenic plant comprising a recombinant DNA construct comprising a promoter, a sequence encoding the exogenous protein, a termination sequence and a translocation sequence encoding a secretion signal peptide;
- propagating the plant so that the exogenous protein from the DNA construct becomes expressed; and
- extracting the protein from the plant wherein the plant is aloe, the DNA construct contains a secretion signal peptide so that at least a portion of the exogenous protein becomes translocated into gel of the aloe leaves, and the exogenous protein is extracted in the leaf gel.
This application was rejected for insufficient disclosure during substantive examination on the grounds that the description failed to provide any experimental evidence showing that the aloe plant transformed by the vector or construct of this invention could be successfully obtained and stably expressed exogenous protein. A reexamination request was filed and finally a reexamination decision revoking the rejection decision was issued.
In the reexamination decision, the panel of the Patent Reexamination Board states that if those skilled in the art, based on the description and the prior art, could perform the claimed technical solution, solve the corresponding technical solution and produce expected technical effect, then the description sufficiently discloses the invention. The panel notes that plant genetic transformation research has developed rapidly since a first transgenic plant was obtained in 1983 and the methods involved in producing an exogenous protein in a transgenic plant, including the design of DNA construct for transforming plant, the constructing method and the method for obtaining a transgenic plant, are conventional in the art and described in the specification of the patent application. The panel further notes that the examples of the application specifically describe the preparation of construct containing exogenous gene, transformation of plant cells with construct, screen of positive transformant, and cultivation of a plant from positive transformant. On this basis, the panel concludes that based on the disclosure of the application and the prior art, the claimed invention can be carried out and can solve the technical problem intended to be solved.
The panel deems that the present invention has successfully obtained the transgenic plants based on the statement in the specification that the aloe plant in figure 1 is a transgenic plant in which a genetic construct has been stably integrated and expressed and the fact that there is no counterevidence. The panel also deems that those skilled in the art, based on the specification and the conventional technical means, could obtain a transgenic aloe with active exogenous protein in its leaf gel, now that the specification has recited that the expressed protein is secreted into the leaf gel of aloe plant and it is conventional technical means to use a signal peptide to direct protein translocation. The panel also confirms that a post-filing document showing that the exogenous protein is expressed in the aloe plant could support the sufficient disclosure.
In this case, although the specification of the application did not include examples directly showing that the transgenic aloe plant could be successfully prepared and stably expressed exogenous protein, the applicant utilizes the combination of the figures which show a photograph of the aloe plant and the prior art knowledge to successfully overcome the objection of insufficient disclosure. Thus, when facing the objection of insufficient disclosure, if the description indeed failed to provide examples directly showing the effect of the invention, the applicant could try to find support from the whole application documents and the prior art knowledge. Post-filing experimental data cannot be used as the only basis of proving sufficient disclosure, but can be submitted in support of arguments based on the disclosure of the application and the prior art.
We have successfully represented the applicant to obtain its patent right for this application.