In Re-examination Decision 68977 (1F137820), the Patent Re-examination Board overturned a rejection that was based on insufficient disclosure. The application concerned patent number 200680043903.1, which relates to a transgenic aloe plant used for the production of protein and the method for its production. In particular, Claim 1 concerned a method for producing a protein exogenous to the plant, which comprised of:
- providing a transgenic plant with 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 is expressed; and
- extracting protein from the plant where:
- the plant is an aloe;
- the DNA construct contains a secretion signal peptide so that at least a portion of the exogenous protein becomes translocated into the gel of the aloe leaves; and
- the exogenous protein is extracted from the leaf gel.
This application was rejected for insufficient disclosure during 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 express exogenous protein. A re-examination request was filed and a re-examination decision revoking the rejection decision was issued.
During re-examination, the Patent Re-examination Board stated 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 the expected technical effect, the description sufficiently disclosed the invention.
The panel noted that plant genetic transformation research has developed rapidly since the first transgenic plant was created in 1983 and the methods involved in producing an exogenous protein in a transgenic plant, including the design of a DNA construct for transforming a 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 noted that the examples provided in the application specifically describe:
- the preparation of construct containing the exogenous gene;
- the transformation of plant cells with the construct;
- the screen of positive transformant; and
- cultivation of a plant from positive transformant.
On this basis, the panel concluded that based on the disclosure of the application and the prior art, the claimed invention could be carried out and could solve the technical problem as it was intended to be solved.
The panel deemed that the invented process can be used to successfully obtain 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 was no counter evidence.
The panel also deemed 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, using the specification that the expressed protein is secreted into the leaf gel of an aloe plant and it is a conventional technical method to use a signal peptide to direct protein translocation. The panel also confirmed that a post-filing document showing that the exogenous protein is expressed by the aloe plant could support 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 express exogenous protein, the applicant utilised 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.
On this basis, when facing the objection of insufficient disclosure, if the description fails to provide examples directly showing the effect of the invention, the applicant can attempt to find support from the whole of the application documents and the prior art knowledge. Post-filing experimental data cannot be used as the only basis for proving sufficient disclosure, but can be submitted in support of arguments based on the disclosure of the application and the prior art.