The Dolcera Blog

Claims 1,4,15 & 18-21 of US Patent Application No. 10/346,493(”Appln. 493″) filed by “Gleave”(Martin Gleave and Maxim Signaevsky)  were rejected by the examiner as anticipated or obvious under 35 U.S.C 102/103. Gleave appealed against the decision but the Federal circit affirmed the rejection.

Appln. 493(titled “Bispecific Antisense Oligonucleotides that inhibit  IGFBP-2 and IGFBP-5 and Methods of Using the same”) claims antisense oligodeoxynucleotides, pharmaceutical compositions containing them and method of treating cancer by using them.

The claims rejected by the examiner included Composition claims consisting of these antisense oligodeoxynucleotides, which were claimed to be complementary to a portion of a gene encoding human IGFBP-2/ IGFBP-5, “wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5″.

The examiner rejected the present claims over anticipation by prior art PCT Publication of Wraight et al. (WO 00/78341).This publication disclosed every fifteen-base long sense oligodeoxynucleotide in the IGFBP-2 gene and further also disclosed that these oligodeoxynucleotides may be bispecific(capable of acting as a inhibitor of IGFBP such as IGFBP-2 and/or IGFBP-3).

For a reference/document to be anticipatory, the following requirements should be satisfied:

1.     The reference should disclose each and every element of the claimed invention, explicitly or inherently. Those elements must be combined or arranged in the same way as in the claim.

2.     The reference must enable “one of ordinary skill in the art to make the invention without undue experimentation”.

Gleave claims that Wraight does not describe any particular individual antisense species, there are no particular selections and no understanding of what targets would be useful. Thus Gleave primarily argues that although a large and exhaustive list was disclosed to the public, no basis was provided for selecting some individual members over the others. In effect, he argues that what is actually disclosed is not more than a generic concept underlying the list.

However, the court held that Gleave’s argument failed for two reasons. The list disclosed in Wraight’s  application anticipates Gleave’s claims. Secondly, Gleave’s argument that Wraight’s application is a generic concept stating that one could make antisense constructs that target IGBFP, was also nullified as court held that a person of ordinary skill in the art having the IGFBP sequence is capable of envisioning how to make antisense sequences. Thus, Gleave does not hold right to patentability over Wraight.

In conclusion, the discovery of a new property/use of known composition even when the use/property are non-obvious over prior art cannot impart patentability to claims of the known composition. If a new use is  discovered, patentability can only be claimed for that method of use.

-Priyanka Goyal

Knowledge Scientist

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